AU2009200284B2

AU2009200284B2 - A weaning and decision support system

Info

Publication number: AU2009200284B2
Application number: AU2009200284A
Authority: AU
Inventors: Fleur T. Tehrani
Original assignee: Individual
Current assignee: Individual
Priority date: 2009-01-29
Filing date: 2009-01-29
Publication date: 2012-11-15
Anticipated expiration: 2029-01-29
Also published as: AU2009200284A1

Abstract

A system for mechanical ventilation treatment is described. In one embodiment the system provides advice on treatment and/or weaning of patients from mechanical 5 ventilation based on the patient's conditions. In another embodiment the system includes apparatus to monitor and analyze the patient's data and data from the mechanical ventilator and controls the ventilator automatically.

Description

1 A WEANING AND DECISION SUPPORT SYSTEM FOR MECHANICAL VENTILATION FIELD OF THE INVENTION 5 [0001] This invention relates generally to technology for weaning and treatment of patients on mechanical ventilation. More specifically, the invention relates to a method and apparatus for open or closed loop control of a mechanical ventilator through monitoring and analysis of patient and ventilator input data. BACKGROUND OF THE INVENTION 10 [0002] Mechanical ventilation is one of the most widely used techniques of treatment of patients particularly in the intensive care units of hospitals. Proper management of patients on the ventilator and safe and timely weaning and extubation of patients are the objectives that serve as key factors in expediting recovery and reducing the mortality and morbidity risks associated with the treatment. A system that can provide expert advice to clinicians 15 for such treatment and that can automatically and safely wean the patients from the ventilator can be a valuable tool in achieving these objectives. [0003] Attempts to provide expert advice for mechanical ventilation have been described. There have been systems for treatment of ARDS patients only. See D. F. Sittig et al., "Implementation of a Computerized Patient Advice System Using the HELP Clinical 20 Information System," Computers and Biomedical Research, Vol. 22, pages 474-487, 1989. There have also been expert and control systems developed for use in pressure support mechanical ventilation mode only. See M. Dojat et al., "Evaluation of a Knowledge-Based System Providing Ventilatory Management and Decision for Extubation," American Journal of Respiratory and Critical Care Medicine, Vol. 153, pages 997-1004, 1996.

2 [0004] However, the previous techniques were developed for use in specific ventilation modes or were designed for specific groups of patients. What is needed is an expert and control system for a mechanical ventilator that may be customized according to patient needs to address a broader field of respiratory conditions and therapies. 5 [0005] In this specification where reference has been made to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the features of the invention. Unless specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such sources of information, in any jurisdiction, are prior art, or form 10 part of the common general knowledge in the art. [0006] It is therefore an object of the present invention to provide an improved weaning and decision support system for mechanical ventilation or to overcome the above shortcomings or address the above desiderata, or to at least provide the public with a useful choice. 15 SUMMARY OF THE INVENTION [0007] In a first aspect there is provided a method encoded on a data storage medium as executable software for optimizing mechanical ventilation of a patient, the method comprising steps of: (a) receiving patient input data representing respiratory airway resistance 20 (RES), respiratory compliance (COMP), and data indicative of patient's ideal body weight (WEIGHT); (b) receiving data representing patient oxygen level (P02); 3 (c) receiving input data representing measured spontaneous breathing rate (FSP), tidal volume (VTMS), inspired oxygen fraction (FIO), and positive end-expiratory pressure (PEEP); (d) determining optimal ventilation level and optimal respiratory rate for the 5 patient based on data received in step (a); (e) determining a level of controlled ventilation for the patient based on the FSP, the VTMS, the optimal ventilation level, and the optimal respiratory rate; (f) determining required levels of FIO and PEEP based on the patient oxygen level data received in step (b) and the patient FIO and PEEP data received in step 10 (c); and (g) generating outputs representing the required levels of FIO, PEEP, and the controlled ventilation for a next breath of the patient; the steps performed by a processor executing the software. 15 [0008] Preferably step (e) further comprises determining whether to start or continue weaning the patient based on the FSP, the VTMS, the optimal ventilation level, and the optimal respiratory rate, and if so, determining the level of controlled ventilation for optimal weaning. 20 [0009] Preferably the optimal respiratory rate is computed to minimize respiratory work rate.

4 [0010] Preferably data received in step (a) includes data representing patient body temperature (TEMP). [0011] Preferably the data representing inspiratory to expiratory time ratio (TI/TE) is 5 provided in step (c). [0012] Preferably the optimal ventilation level, MV, in liters/minute is calculated as: MV = V' + a x V' x (TEMP - 37) for TEMP ;> 37, MV = V' for TEMP < 37, 10 where V' = p x WEIGHT, WEIGHT is in Kg, TEMP is in degrees C, and a and Pare constants. [0013] Preferably the optimal respiratory rate is calculated as: -K'xVD+ (K'xVD)2+4xK'xRESx2 X(L )xVD Fl= 60 x60 F=60x 2x RES xfl2 x VD 15 where Fl is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - F1 x VD. [0014] Preferably the method further comprises adjusting the TI/TE ratio so that 20 expiration time TE = 0.5/fnax, where fmax is a maximum allowed respiratory rate calculated as: fmax = 1/ (5 x RES x COMP).

5 [0015] Preferably step (b) of the method further comprises receiving data representing patient carbon dioxide level (PCO2) and wherein step (d) further comprises determining optimal ventilation level and optimal respiratory rate for the patient based on data received in step (a) and step (b). 5 [0016] Preferably the optimal respiratory rate is computed to minimize respiratory work rate. [0017] Preferably the optimal ventilation comprises optimal alveolar ventilation, VALV, 10 which is calculated as: VALV = (VAO + VAC) x VALV(rest) where VAO = 4.72 x 10- 9 x (104 - PaO2) 4

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9 for PaO2< 104 mm Hg, and VAO = 0 for PaO2> 104 mm Hg, VAC = C1 x PaCO2 - C2 for PaCO2 greater than a predefined value and VAC =0 otherwise, and VALV(rest) = K x WEIGHT, where VALV and VALV(rest) 15 are alveolar ventilation and alveolar ventilation at rest in liters/minute respectively, PaO2 and PaCO2 are partial pressures of oxygen and carbon dioxide in patient's arterial blood in mmHg respectively, and C1, C2, and K are constants. [0018] Preferably the optimal respiratory rate is calculated as: K'xVD+ (K'xVD)2+4xK'xRESX12X(VAL)xVD 20 F1=60x 60 2xESxH2xVD 6 where F1 is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - F1 x VD. 5 [0019] Preferably P02 is set equal to measured arterial oxygen saturation of the patient (SPO2), and wherein FIO is computed by using a sequential procedure, with SPO2 compared to predefined threshold levels successively and FIO adjusted accordingly. [0020] Preferably the sequential procedure including the following steps: 10 comparing SPO2 with a high threshold value; if SPO2 is higher than or equal to the high threshold value, reducing FIO down to a predefined low value FRI but not lower than FRI as: new FIO = FRI + (FIO-FR1) x K" where K" is a factor less than 1; 15 if SPO2 is lower than the high threshold value, comparing SPO2 with a lower second threshold value, and if it is higher than or equal to the lower second threshold value, reducing FIO down to a predefined value FR2 but not lower than FR2 as: new FIO = FR2 + (FIO-FR2)xK"; if SPO2 is lower than the second threshold value, comparing it with a lower 20 third threshold value, and if SPG2 is higher than or equal to the third threshold value, raising FIO to a predefined value FR3 if it is lower than FR3; 7 if SPO2 is lower than the third threshold value, comparing it with a lower fourth threshold value, and if it is higher than or equal to the fourth threshold value, raising FIO to a predefined value FR4 if it is lower than FR4; and if SPO2 is lower than the fourth threshold value, comparing FIO with a 5 predefined high value, and if it is lower than the predefined high value, raising FIO to the predefined high value. [0021] Preferably PEEP is increased incrementally if SPO2 is found to be lower than the fourth threshold value and if a predefined minimum time has elapsed since a most recent 10 adjustment in PEEP. [0022] Preferably the method comprises determining a ratio of PEEP to FIO (RATIO); comparing RATIO to predefined minimum and maximum values for the 15 ratio; increasing PEEP if RATIO is lower than the minimum value and a predefined minimum time has elapsed since a most recent adjustment in PEEP; and decreasing PEEP if RATIO exceeds the maximum value to bring RATIO lower than or equal to the maximum value. 20 [0023] Preferably the method comprises comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; 8 comparing VTMS to a VTMS acceptance range; and if FSP and VTMS are both within their respective acceptance ranges, determining that weaning should start or continue with a lowered level of controlled ventilation. 5 [0024] Preferably the method comprises comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and 10 if FSP exceeds a maximum of the FSP acceptance range, if VTMS is less than a maximum of the VTMS acceptance range, and if P02 exceeds a predefined value, determining that weaning should continue with an increased level of controlled ventilation. [0025] Preferably step (b) further comprises receiving data representing patient carbon 15 dioxide level (PCO2); wherein step (d) further comprises determining optimal ventilation level and optimal respiratory rate for the patient based on data received in step (a) and step (b); and further comprising comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; 20 comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with lowered level of controlled ventilation if started already, if FSP and VTMS are both within their respective acceptance ranges.

9 [0026] Preferably step (b) further comprises receiving data representing patient carbon dioxide level (PCO2); wherein step (d) further comprises determining optimal ventilation level and optimal respiratory rate for the patient based on data received in step (a) and step (b); and 5 further comprising comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with a lowered level of controlled ventilation if started already, if FSP and VTMS are both within their 10 respective acceptance ranges, if P02 exceeds a predefined value, and if PCO2 is below a predefined level. [0027] Preferably the method comprises determining that weaning should start, or should continue with a lowered level of controlled ventilation if already started, if required FIO is 15 below a predefined value and if required PEEP is also below a predefined value. [0028] Preferably the method is implemented on a digital computer wherein one or more of the data in steps (a) through (c) is provided manually to the computer through a user interface. 20 [0029] Preferably the method is implemented on a digital processor wherein the input data is provided to the processor automatically.

10 [0030] In a further aspect there is provided an apparatus for optimizing mechanical ventilation of a patient, comprising: a computing system; digital readable memory coupled to the computing system; and 5 transducers providing patient input signals to the computing system representing respiratory airway resistance (RES), respiratory compliance (COMP), and ventilation data representing patient's spontaneous breathing rate (FSP), and measured tidal volume (VTMS); wherein the computing system executing a program stored in the memory 10 determines output data representing optimal ventilation level and optimal respiratory rate of the patient based on data indicative of patient's ideal body weight (WEIGHT) stored in memory and data representing RES and COMP, and provides output data representing optimal ventilation and optimal respiratory rate and a controlled level of mechanical ventilation based on the optimal ventilation data, the optimal respiratory rate data, FSP, and 15 VTMS. [0031] Preferably the apparatus further comprises a transducer providing input signal representing patient's measured oxygen level (P02) to the computing system. 20 [0032] Preferably the transducers include a pulse oximeter providing the P02 input signal and one or more sensors providing the RES and COMP signals.

11 [0033] Preferably the apparatus further comprises a transducer providing input signal representing measured carbon dioxide level (PCO2) of the patient and wherein the computing system executing the program further determines, based on P02 and PCO2, required levels of ventilation and respiratory rate of the patient. 5 [0034] Preferably the transducers include an end-tidal carbon dioxide analyzer for providing the PCO2 patient input signal. [0035] Preferably the transducers further provide to the computing system patient input 10 signals representing positive end-expiratory pressure (PEEP) and inspired oxygen fraction (FIO) and wherein the computing system executing the program determines output data representing required PEEP and required FIO and supplies the required PEEP and the required FIO to the mechanical ventilator. 15 [0036] In another aspect there is provided a method for automatically controlling a mechanical ventilator to wean a patient from mechanical ventilation, comprising the steps of: (a) providing patient data representing respiratory airway resistance (RES) and respiratory compliance (COMP); 20 (b) providing patient data indicative of ideal body weight (WEIGHT); (c) providing patient data representing measured oxygen level (P02); (d) providing patient data representing tidal volume (VTMS) and spontaneous breathing rate (FSP); 12 (e) providing patient data representing positive end-expiratory pressure (PEEP); (f) determining based on data provided in steps (a) and (b), optimal ventilation and optimal respiratory rate of the patient; (g) determining whether weaning should start or continue and a level of controlled 5 mechanical ventilation based on the optimal ventilation, the optimal respiratory rate, and patient data provided in step (d); and (h) providing a control signal representing a controlled ventilation level based on data from step (g) and supplying the control signal to the mechanical ventilator to control it automatically for a next breath of the patient. 10 [0037] Preferably data received in step (b) include data representing patient body temperature (TEMP). [0038] Preferably step (c) further comprises providing data representing patient carbon 15 dioxide level (PCO2) and wherein data provided in steps (a), (b), and (c) are used in step (f) to determine the optimal ventilation and the optimal respiratory rate of the patient. [0039] Preferably the method further includes providing patient input data representing inspired fraction of oxygen (FIO), and wherein the FIO data, data in step (c), and data 20 representing PEEP are also used in step (g) to determine whether weaning should begin. [0040] Preferably the optimal ventilation, MV, in liters/minute is calculated in step (f) as: MV = V'+ a x V' x (TEMP - 37) for TEMP > 37, 13 MV = V' for TEMP < 37, where V' = p x WEIGHT, WEIGHT is in Kg, TEMP is in degrees C, and a and P are constants. 5 [0041] Preferably the optimal respiratory rate is calculated as: 2 ALV -K'xVD+ (K'xVD)2+4xK'xRESx2 x( 6 )xVD F1= 60 x60 F=60x2 x RES x H 2 x VD where F 1 is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - F1 x VD. 10 [0042] Preferably VD is calculated as: VD = 0.0026 x WEIGHT. [0043] Preferably the optimal ventilation comprises optimal alveolar ventilation, VALV, which is calculated as: 15 VALV = (VAO + VAC) x VALV(rest) where VAO = 4.72 x 10- 9 x (104 - PaO2) 4

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9 for PaO2< 104 mm Hg, and VAO = 0 for PaO2> 104 mm Hg, VAC = Cl x PaCO2 - C2 for PaCO2 greater than a predefined value and VAC =0 otherwise, and VALV(rest) = K x WEIGHT, where VALV and VALV(rest) are alveolar ventilation and alveolar ventilation at rest in liters/minute respectively, PaO2 20 and PaCO2 are partial pressures of oxygen and carbon dioxide in patient's arterial blood in mmHg respectively, and C1, C2, and K are constants.

14 [0044] Preferably PaCO2 is obtained from: PaCO2 = PCO2 + K1, where PCO2 is patient's end-tidal pressure of carbon dioxide and K1 is a constant. 5 [0045] Preferably PaO2 is obtained as: Pao2 = lnl - (SPO2)05 +C3 0.046 where SPO2 is patient's arterial oxygen saturation measured by pulse oximetry and C3 is a shifting constant that depends on patient blood pH level. 10 [0046] Preferably the optimal respiratory rate is calculated as: K'xVD+ (K'xVD)2+4xK'xRESxH2 X(L )xVD !F1=60x 60 F=60x 2x RESx -2 x VD where F1 is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - F1 x VD. 15 [0047] Preferably VD is calculated as: VD = 0.1698x(VALV/60) + 0.1587. [0048] Preferably the method further comprises 20 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; 15 comparing VTMS to a VTMS acceptance range; and determining that weaning should start or continue with a lowered level of controlled ventilation if FSP and VTMS are both within their respective acceptance ranges. 5 [0049] Preferably the method further comprises comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should continue with an increased level of 10 controlled ventilation if VTMS is below a maximum value of the VTMS acceptance range, if P02 exceeds a predefined value, and if FSP exceeds a maximum value of the FSP acceptance range. [0050] Preferably the method further comprises 15 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with lowered level of controlled ventilation if started already, if FSP and VTMS are both within their 20 respective acceptance ranges. [0051] Preferably the method further comprises 16 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should continue with increased level of controlled 5 ventilation if VTMS is lower than a maximum value of the VTMS acceptance range, if P02 exceeds a predefined value, if PCO2 is below a predefined value, and if FSP exceeds a maximum value of the FSP acceptance range. [0052] Preferably the method further comprises 10 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with a lowered level of controlled ventilation if started already, if FSP and VTMS are both within their 15 respective acceptance ranges, if P02 exceeds a predefined value, and if PCO2 is below a predefined value. [0053] Preferably the method further comprises comparing FSP to an FSP acceptance range based on the determined 20 optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with a lowered level of controlled ventilation if started already, if FSP and VTMS are both within their 17 respective acceptance ranges, if P02 exceeds a predefined value, if PCO2 is below a predefined value, if FIO is lower than a predefined value, and if PEEP is lower than a predefined value. 5 [0054] Preferably the method comprises an advisory decision support system, wherein the generated outputs in step (g) cause instructions for a user. [0055] Preferably the outputs generated in step (g) are signals that are supplied to a mechanical ventilator to control it automatically. 10 [0056] Preferably the outputs generated in step (g) are signals that are supplied to a mechanical ventilator to control it automatically. [0057] In yet a further aspect the present invention consists in a method encoded on a 15 data storage medium as executable software for optimizing mechanical ventilation of a patient as herein described with reference to any one or more of the accompanying drawings. [0058] In yet a further aspect the present invention consists in an apparatus for 20 optimizing mechanical ventilation of a patient as herein described with reference to any one or more of the accompanying drawings.

18 [0059] In yet a further aspect the present invention consists in a method for automatically controlling a mechanical ventilator as herein described with reference to any one or more of the accompanying drawings. 5 [0060] A method of providing treatment advice for patients on mechanical ventilation includes steps of analyzing patient's and ventilator's data, computing and recommending optimal ventilatory requirements, suggesting on whether weaning should be started, continued or stopped, and providing appropriate warning messages when necessary. A system can also be implemented by using an apparatus including sensors for continuous 10 monitoring of patient data. [0061] The system may use data representative of carbon dioxide and oxygen levels of the patient, the respiratory mechanics data such as airway resistance and respiratory compliance, the patient's ideal body weight and temperature, the settings on the ventilator such as tidal volume, respiratory rate, positive end-expiratory pressure, the inspiratory to 15 expiratory time ratio, the inspired oxygen concentration, the maximum allowed levels of volume and pressure on the ventilator for the patient, measured tidal volume and the spontaneous breathing rate of the patient as well as the mode of the mechanical ventilator. [0062] The system is designed to help regulate patient's arterial blood gases within an acceptable range, provide patient's data over time to the clinician, and to expedite weaning 20 from the ventilator in a safe and timely manner. It provides advice on how much ventilation the patient requires and recommends ventilator settings to minimize the respiratory work rate. It determines the optimal levels of inspired oxygen fraction and positive end-expiratory pressure for the patient. It provides advice on other settings of the 19 ventilator such as the inspiratory to expiratory time ratio and warns the clinician of any untoward condition of the patient. It recommends whether weaning should be started, continued or stopped. It has the capability of providing advice in a wide range of ventilation modes and for different patients on mechanical ventilation. 5 [0063] A system of the invention can also be implemented by using an apparatus including sensors for continuous monitoring of patient data. The system can provide automatic control of the ventilator and automatic weaning from the ventilator. This embodiment includes an apparatus for monitoring and analysis of the required data. The apparatus may include a computing system, digital readable memory coupled to the 10 computing system, and transducers providing input signals to the computing system that may represent data such as airway resistance, respiratory compliance, spontaneous breathing rate, and measured tidal volume. Control of the ventilator may be achieved by providing the control signals to the ventilator automatically. This embodiment of the invention can be used for automatic weaning of the patient from the ventilator. The 15 automatic weaning procedure will continue until the patient is ready for extubation, or if patient's conditions deteriorate, the system automatically increases the ventilator's support for the patient and generates a warning message to the clinician. [0064] As used herein the term "and/or" means "and" or "or", or both. [0065] As used herein "(s)" following a noun means the plural and/or singular forms of 20 the noun. [0066] The term "comprising" as used in this specification means "consisting at least in part of'. When interpreting statements in this specification which include that term, the features, prefaced by that term in each statement, all need to be present, but other features 20 can also be present. Related terms such as "comprise" and "comprised" are to be interpreted in the same manner. [0067] It is intended that reference to a range of numbers disclosed herein (for example, 1 to 10) also incorporates reference to all rational numbers within that range (for example, 5 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9 and 10) and also any range of rational numbers within that range (for example, 2 to 8, 1.5 to 5.5 and 3.1 to 4.7). [0068] To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and application of the invention will suggest themselves without departing from the scope of the invention as defined in the 10 appended claims. The disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting. [0069] Other aspects of the invention may become apparent from the following description which is given by way of example only and with reference to the accompanying drawings. 15 BRIEF DESCRIPTION OF THE DRAWINGS [0070] For the purpose of illustrating the invention, a presently preferred form of the invention is shown in the drawings. However, it is understood that this invention is not limited to the precise arrangements and instrumentalities shown. 20 [0071] FIG. 1 is a block diagram depicting general applications of the invention. [0072] FIG. 2 is a block diagram of a Monitor, Analyzer, and Control Apparatus according to one embodiment of the invention.

21 [0073] FIG. 3 shows a virtual switch board displayed on a computer screen that provides a user with initial options for operating software according to the invention. [0074] FIGS. 4A-4E are a flow chart illustrating one embodiment of a method according to the invention, including a preferred sequence of steps executable by a programmable 5 system according to the invention. [0075] FIG. 5 is a process flow diagram of a method for optimizing mechanical ventilation of a patient according to the invention. [0076] FIG. 6 is a process flow diagram of a method for automatically weaning a patient from mechanical ventilation according to the invention. 10 DETAILED DESCRIPTION [0077] The present invention is designed for a wide range of patients and is not limited to any specific mode of ventilation. Unlike previous rule-based techniques, a system or method according to the invention operates, or derives many of its rules, on the basis of the 15 conditions of individual patients. Therefore the system or method is quite responsive to the individual patient's bodily requirements. A system or method according to the invention may be used to achieve either open loop or closed loop control. In open loop control, a clinician may use the invention as an expert system or decision-support system, and may manually adjust or operate a mechanical ventilator based on output automatically provided 20 by the decision-support system. In the closed loop scenario, the invention may provide a fully automatic control system for monitoring and operating the mechanical ventilator, while still allowing for a possible manual override by the clinician.

22 [0078] Referring to the drawings, wherein like numerals represent like elements, there is illustrated in FIG. 1 a block diagram depicting general application of the invention. Data from the mechanical ventilator designated as 10 is provided via switched lines 15 to the Monitor, Analyzer, and Control apparatus 11. The switch in lines 15 is closed when data 5 from the ventilator is sent automatically to apparatus 11. Apparatus 11 also receives patient data from one or more transducers through lines 16. Apparatus 11 sends outputs to computer 12 and communicates back and forth with computer 12 through switched lines 17 which preferably represent an RS232 or USB communication port. The control outputs of apparatus 11 are provided through switched lines 14 to mechanical ventilator 10 when the 10 invention is used to automatically control the ventilator. [0079] Switches in switched lines 14, 15, 16, and 17 may be manual or automatic switches. If automatic switches are used, they may include automatic switching means, such as relays, transistors, logic gates, and other solid state devices, and may be physically located at mechanical ventilator 10, apparatus 11, or computer 12, as desired. In another 15 embodiment, one or more of switched lines 14, 15, 16, and 17 may represent a wireless connection. [0080] Whether control is manual or automatic, a user interface 13 may be provided to allow a human user or clinician to enter data into computer 12 through a communication line 18. User interface 13 may be a keyboard, mouse, touchscreen, microphone, or other 20 input device. [0081] Computer 12 may be any computing system having a processor coupled to memory, and may include operating system software. Computer 12 may be or may include a customized digital controller such as an FPGA or ASIC or other processor programmed 23 to execute the specific algorithms or methods of the present invention as disclosed herein, or computer 12 may be a personal computer system such as a desktop or laptop unit running an operating system such as Windows, Mac OS, Unix or Linux, and also having loaded in its memory a custom software application for executing the algorithms or 5 methods of the present invention. In one embodiment, computer 12 may include a display unit such as a CRT or LCD monitor. The display unit may display options provided to a clinician by the custom software, and may display data received from a patient, data received from mechanical ventilator 10, data received from apparatus 11 such as instructions or warnings, or data input by the clinician through user interface 13. 10 [0082] The human operator may control the system using the computer 12 and user interface 13. At least three preferred modes of application of this invention may be recognized: (i) Decision Support mode, (ii) Open Loop manual mode, and (iii) Closed Loop automatic mode. [0083] In Decision Support mode, the system is installed on computer 12 and the 15 invention is used as a decision support tool. Patient and ventilator data are input to the system via user interface 13 by the human operator. Apparatus 11 is not needed in this mode and is not used. Adjustments of the ventilator 10 are done manually by the human operator. [0084] In Open Loop manual mode, the system is installed on either computer 12 or on a 20 processor incorporated in apparatus 11 that receives data from ventilator 10 and the patient on lines 15 and 16, respectively. In this mode, the human operator controls the ventilator 10 manually. There is no automatic control of ventilator 10 by the system of the invention and lines 14 are open.

24 [0085] In Closed Loop automatic mode, the system is installed on either computer 12 or on a processor incorporated in apparatus 11 that receives data from the ventilator 10 and the patient on lines 15 and 16, respectively. Ventilator 10 is controlled automatically by the invention through preferably lines 14. The human operator supervises the system and 5 can change the data or intervene at any time by using computer 12 and user interface 13. One of the applications of this mode is in automatic weaning of the patient from the ventilator. The control outputs to ventilator 10 are updated automatically at predefined intervals and weaning is continued until the patient is ready for extubation or needs to have increased ventilatory support again in which case the system generates a warning message 10 to the clinician and increases the level of support by ventilator 10. [0086] FIG. 2 shows a block diagram of the preferred Monitor, Analyzer, and Control apparatus 11. It includes a Digital Processor and Control Unit 20, hereinafter control unit 20. This unit may have one or more digital controllers which may preferably be Micromint Brand BCC 52 BASIC controllers. The input data from ventilator 10 is applied to an 15 analog to digital converter (A/D) board 33 through lines 15. The outputs of A/D 33 are applied to control unit 20 through lines 37. This data may include ventilatory data such as set tidal volume, measured tidal volume, respiratory rate, the spontaneous breathing rate, the peak inspiratory pressure, the positive end-expiratory pressure, the inspiratory to expiratory time ratio, the maximum allowed levels of volume and pressure, and data 20 indicative of the mode of ventilation. [0087] Patient oxygen level at 24 is preferably measured by using a transducer such as a pulse oximeter 21. Output 27 of pulse oximeter 21 is applied to an A/D converter 30, and the digital output from A/D converter 30 is applied to control unit 20 at line 34. The 25 patient's CO 2 level at 25 may be measured by using a transducer such as an end-tidal CO 2 analyzer 22. Output 28 of analyzer 22 is applied to an A/D converter 31, and the digital output from A/D converter 31 is provided at line 35 to control unit 20. The patient's respiratory compliance and airway resistance may be measured by using a transducer such 5 as a respiratory mechanics monitor 23, which receives its inputs from the patient at 26 and provides its outputs at line 29 to an A/D board 32. The outputs of A/D board 32 are applied at line 36 to control unit 20. The control unit 20 communicates with computer 12 through a communication link 17, which is preferably RS232 or USB. If the system is used for automatic control of the ventilator, such as in a closed loop automatic mode, the output 10 of control unit 20 may be applied at line 38 to one or more D/A converters 19, and the outputs of D/A converters 19 may be applied to ventilator 10 preferably through lines 14 as shown. [0088] It should be noted that if the system is installed on computer 12 and computer 12 is equipped with a software package such as LabView for data collection and analysis, the 15 system inputs can be applied to computer 12 and the digital processor and control unit 20 may not be needed. Also, if the Monitor, Analyzer, and Control Apparatus 11 is incorporated in the Mechanical Ventilator 10, A/D boards 33 and D/A boards 19 may not be needed. It is also clear that apparatus 11 may not be needed if the system is installed on computer 12 and all the controls and adjustments are done by a human operator. 20 [0089] FIG. 3 shows the main options of the software used in a preferred method of the invention. In one embodiment, where computer 12 provides a clinician with a graphical user interface on a display unit, the main options may be displayed as a virtual switchboard, as indicated in the figure. To access these options, a user starts up the 26 software in an initial step 100. At step 100 at the start of the program, the user is provided with four options, any one of which may be directly selected after step 100. From left to right, the first option 110 is a Help & Guidance option, which allows a user to view the software guidelines and get help. The second option 120 is a Create New Patient File 5 option, which allows a user to create a new file for a new patient. The third option 130 is Follow Up on An Existing Patient. This option allows a user to continue use of the software for a patient whose personal history may already be logged in the computer memory or who has had prior respiratory therapy on the system according to the invention. The fourth option 140 is View Patient's Data, which allows a user to view a patient's 10 accumulated data stored in system memory. [0090] In one embodiment, selecting option 120 allows a user to enter patient data such as name, ID number, gender, ideal body weight, etc., and begin respiratory therapy for the patient. For example, in Decision Support mode, the user selecting option 120 may then enter ventilator data by reading data from the mechanical ventilator 10 and entering that 15 data into computer 12 via user interface 13. The user may then wait for computer 12 to output an instruction, responsive to patient and ventilator input data, for display on the display unit. The user may receive the instruction by reading the display unit, and then take appropriate action, for example, by adjusting a control on mechanical ventilator 10, adjusting a sensor connected to the patient, or by taking some action to stop the respiratory 20 therapy. In Open Loop Manual mode, the user selecting option 120 may need only enter patient nominal data such as name, ideal body weight, etc. Computer 12 will then automatically provide decision support to the clinician by displaying instructions for respiratory therapy, and the clinician may then act on the instructions by manually 27 controlling mechanical ventilator 10 in accordance with the instructions. In Closed Loop Automatic mode, the user selecting option 120 may need only enter patient nominal data, then allow computer 12 to automatically administer respiratory therapy to the patient (including weaning the patient) through closed-loop control as described above with 5 reference to FIGS. 1 & 2, and according to automated processes described below in further detail. In this mode, the user may supervise the automatic therapy, and may at any time intervene through user interface 13. For existing patients, a user selecting option 130 need not enter nominal data for the patient, as that data may already be logged in computer memory. After selecting option 130, respiratory therapy or weaning may be administered 10 in any desired mode. [0091] FIGS. 4A-4E show a process flow chart of one embodiment of a preferred sequence of steps executed to carry out a method of the invention. Those skilled in the art will appreciate that the sequence of steps may be easily reduced to source code instructions for input to and execution by a processor or computer using standard programming 15 languages such as Basic, Visual Basic, or other languages. As can be seen after the start of the flow chart at 200, the input data are read at 202. The input data may include patient and ventilator data such as patient's ideal body weight (WEIGHT), body temperature (TEMP), respiratory airway resistance (RES), respiratory compliance (COMP), CO 2 level (PCO2), arterial oxygen saturation (SPO2), as well as positive end-expiratory pressure 20 (PEEP), the inspired oxygen fraction (FIG), total respiratory rate (F2), the inspiratory to expiratory time ratio (TI/TE), the spontaneous breathing rate (FSP), the peak inspiratory pressure (SPN), tidal volume (VTS), measured tidal volume (VTMS) which may be spontaneous tidal volume for spontaneously breathing patients, maximum allowed tidal 28 volume (VMAX), and maximum allowed pressure (PMAX). Data indicative of the mode of ventilation (VM) is also provided at this stage (e.g. VM is 1 in the pressure control/assist modes and is zero in the volume control/assist modes). [0092] At step 204 that follows, each data is compared to a predefined acceptance range 5 and if it is not within the specified range, its value is rejected and an error message is generated. In the next step, 206, the maximum allowed respiratory rate can be calculated as: FMM = 60/(5xRESxCOMP) where FMM is the maximum allowed respiratory rate in breaths/minute, RES is respiratory 10 airway resistance in cm H 2 0/liter/second, and COMP is respiratory compliance in liter/cmH 2 0. [0093] At the next step, 208, the system checks whether patient's PCO2 data is provided. This data can be provided by many different means and methods of measurement known to those skilled in the art. For example, a gas analyzer may be used to measure the end-tidal 15 CO 2 pressure. The patient's arterial pressure of CO 2 may be obtained as: PaCo2 = PCO2 +KJ where PaCO2 is the partial pressure of CO 2 in the patient's arterial blood, PCO2 may be the end-tidal pressure of CO 2 , and K1 is the difference between PaCO2 and PCO2 which can also be used to set a desired Paco2 level for the patient based on his/her conditions. The 20 unit for the variables in this equation can be mmHg. [0094] If PCO2 data is provided, the next step at 218 is followed in which alveolar ventilation is computed. In this computation, if PaCO2 is less than a predefined threshold 29 level (e.g. 33 mmHg), then the effect of PCO2 on ventilation is set to zero. Otherwise, the net effect of PCO2 on alveolar ventilation is calculated as: VAC = C1XPaCo 2 - C2 where VAC is the ratio of alveolar ventilation as the net effect of PaCo2 to the resting value 5 of alveolar ventilation and C1 and C2 are constants (examples of C1 and C2 are 0.405 and 14.878, respectively, where PaCo2 is in mmHg). Also at step 218, the net effect of patient's oxygen level on ventilation is computed. There are many techniques known to those skilled in the art to measure a patient's blood oxygen level. If the non-invasive method of pulse oximetry is used for such a measurement, the patient's arterial partial pressure of 10 oxygen, Pao2, may be found from arterial oxygen saturation data, SPO2, from the pulse oximeter as: Pao2 = Inl - (SP ±2) . +C3 0.046 where Pao2 is in mmHg and C3 is a constant added to shift and correct Pao2 based on the patient's blood pH level. If the patient's blood pH level is in the 7.45-7.55 range, C3 is set 15 to zero. Otherwise C3 is adjusted by +/- 3.5 mmHg per every -/+ 0.1 deviation in blood pH from the above range. [0095] At step 218, if Pa 0 2 is greater than a predefined value (e.g. 104 mm Hg), then the net effect of oxygen on ventilation is zero. Otherwise: VAO = (4.72x10- 9 ) x (104-Pao 2

)

4

~

9 20 where VAO is the ratio of alveolar ventilation as the net effect of oxygen to the resting value of alveolar ventilation. [0096] At the end of the calculations in step 218, the total alveolar ventilation is calculated as: 30 VALV = (VAO + VAC)xVALV(rest) where VALV and VALV(rest) are alveolar ventilation and alveolar ventilation at rest in liters/min respectively. VALV(rest) may be found as: VALV(rest) = (0.056333/66)xWEIGHTx6O 5 where WEIGHT is the patient's ideal body weight in Kg. WEIGHT may be input to the system or patient's height may be used to determine WEIGHT. If this input is not provided, a default value may be used. Also, if ventilation at rest is provided as input, it will indicate WEIGHT and works the same way as described above. [0097] At step 220 that follows, the computed alveolar ventilation found at step 218 is 10 compared to a predefined minimum and if it is too low, it's value is increased. [0098] At the next step at 222, the patient's respiratory dead space volume is calculated if not provided. The following empirical equation may be used to calculate the dead space volume: VD = 0.1698x(VALV/60) +0.1587 15 where VD is respiratory dead space volume in liters. [0099] In the next step, 224, the optimum respiratory rate to minimize the respiratory work rate is calculated as: 2 ALV -K'xVD + I(K'xVD)2+4xK'xRESx-2l (60)xVD F=60x 2x RES xFI2 x VD where F1 is the optimum total respiratory rate in breaths/minute and K' is the respiratory 20 elastance (reciprocal of compliance, 1/COMP). The above equation is a modified version 31 of an equation derived for optimum frequency of breathing by A. B. Otis et al., "Mechanics of Breathing in Man," Journal of Applied Physiology, Vol. 2, pages 592-607, 1950. [00100] In the next step, 226, the computed breathing frequency is compared with a predefined minimum rate and the maximum rate found in step 206, and it is adjusted if 5 found outside the range. Then at step 228 that follows, minute ventilation is calculated as: MV = VALV +F l x(VD + VED) where VED is the added dead space due to tubes and connections to the ventilator and MV is minute ventilation in liters/minute. [00101] In the next step at 230, the expiratory time is compared to a minimum value and 10 the TI/TE ratio is adjusted if the expiratory time is too short, in order to prevent build up of intrinsic PEEP. The minimum expiratory time may be defined as: TEMIN = 2.5xRESxCOMP where TEMIN is the minimum expiratory time in seconds. [00102] Back to step 208, if patient's PCO2 data is not provided, its value is assumed to 15 be normal (e.g. 39 mmHg), but the program passes to step 210 in which minute ventilation, MV, is calculated by using the patient's ideal body weight and temperature (if temperature input is not provided, a default value such as 37 Celsius may be assumed). The following equations may be used for this calculation: V = (6.7/66)xWEIGHT 20 If TEMP > 370 Celsius, then MV = V + 0.08xV'x(TEMP - 37) Otherwise if TEMP < 37 Celsius, then MV = V [00103] In the next step at 212, the patient's respiratory dead space is calculated. This may be done by using the ideal body weight as: 32 VD = 0.0026xWEIGHT [00104] In the next step at 214, the optimum respiratory rate is computed for minimum respiratory work rate by using the same equation that was discussed in step 224. In order to solve the equation, VALV will be substituted by (MV -FlxVD) in the equation and 5 since MV and VD have already been found at steps 210 and 212, the equation can be solved for F1 by using an iterative trial and error procedure. Then at the next step, 216, the computed respiratory rate is compared to a predefined minimum rate and the maximum rate found in step 206, and is adjusted if it is out of range. Then control passes to step 230 in which the inspiratory to expiratory time ratio is adjusted if necessary as discussed 10 before. [00105] After step 230, the program passes to step 232 in which the patient's oxygen data that may be the arterial oxygen saturation measured by a pulse oximeter (SPO2) is examined. At step 234 that follows, SPO2 is compared to a high threshold value (e.g. 0.95). If SPO2 is greater than or equal to the high threshold value, at step 236, FIO is 15 compared to a low value (e.g. 0.25). If FIO is found to be higher than 0.25 for example, then its value may be reduced at step 238 as: New FIO = 0.25 + (FIO -0.25)x0.65 and then control passes to step 276 which will be described later. Otherwise, if at step 236, FIO is not found to be higher than 0.25, its value is not changed at step 240, and then 20 control passes to step 276. [00106] Back to step 234, if SPG2 is less than the high threshold value (e.g. 0.95), the next step at 242 is performed in which SPG2 is compared to a second threshold value (e.g. 0.94). If SPG2 is greater than or equal to the second threshold value, the next step at 244 is 33 performed in which FIO is compared to another relatively low level (e.g. 0.3). For example, if it is greater than 0.3, then its value may be reduced at step 246 by: New FIO = 0.3 + (FIO -0.3)x0.65 and then control passes to step 276. Otherwise, if at step 244, FIO is not found to be 5 greater than 0.3, its value is not changed in step 248, and then program passes to step 276. [00107] Back to step 242, if SPO2 is less than the second threshold value (e.g. 0.94), then it is compared to a third threshold value (e.g. 0.92) at step 250. If SPO2 is greater than or equal to the third threshold value, then at the next step at 252, FIO is compared to a predefined value (e.g. 0.4). For example, if FIO is less than 0.4, then it is raised to 0.4 at 10 step 254 and program passes to step 276. But if at step 252, FIO is found to be greater than or equal to 0.4, its value is not changed in step 256, and control is transferred to step 276. [00108] Back to step 250, if SPG2 is less than the third threshold value (e.g. 0.92), then at the next step, 258, it is compared to a fourth threshold value (e.g. 0.91). If SPG2 is found to be greater than or equal to the fourth threshold value, at the next step at 260, FIO is 15 compared to another predefined value (e.g. 0.45). If FIO for example is less than 0.45, then its value is raised to 0.45 at step 264 and program passes to step 276. Otherwise FIO is not changed at step 262 and control transfers to step 276. [00109] Back to step 258, if SPG2 is less than the fourth threshold value (e.g. 0.91), then at the next step at 265 a warning message is generated and in the step that follows at 266, 20 FIO is compared to a predefined high value that can be up to 1. In the flow chart a conservative value of 0.65 is used for this high FIO value as an example. If FIO is less than this high value, it is raised to that level at step 268 and then step 270 is performed in which PEEP is increased by a predefined increment (e.g. 2 cm H 2 0), and control passes to 34 step 276. But if at step 266, FIO is not found to be less than the predefined high level, its value is not changed in step 272 that follows and at the next step, 274, PEEP is increased by a predefined increment (e.g. 2 cm H 2 0), and then control passes to step 276. [00110] At the next step, 276, the "RATIO" of PEEP to FIO is calculated as follows: 5 RATIO = PEEP / (FIOx100). This RATIO is compared to a predefined minimum (e.g. 0.12) at step 278. If it is less than the minimum value, PEEP is raised at step 280 and control passes to step 286. If at step 278, RATIO is not found to be low, then at step 282 that follows, it is compared to a predefined maximum value (e.g. 0.24). If RATIO is greater than the maximum value, 10 PEEP is reduced at step 284 and then control transfers to step 286. However, if at step 282, RATIO is not found to be too high either, then no adjustment is done to PEEP and control transfers to step 286. It should be noted that between two successive increases in PEEP, it is preferred that a certain time gap is allowed so that the PEEP change affects the oxygenation status of the patient. Therefore, at steps 270, 274, and 280, PEEP is increased 15 only if adequate time has passed since the last change in PEEP was made, and the time gap may be specified by the clinician. Imposition of the time gap between two successive increases in PEEP is particularly important if the invention is used to automatically control the ventilator. [00111] At step 286 that follows next, minimum and maximum comparison levels for 20 respiratory rate and tidal volume are defined. These levels will be used to determine the status of the patient, and whether the patient should be considered for weaning or not. As examples, these levels may be defined as: FIN = 0.45xF1 35 F2M = 1.8xF1 VTM = 0.7xtidal volume VTL = 1.6xtidal volume. [00112] In the above equations, FIN and VTM are minimum comparison levels for 5 respiratory rate and tidal volume, and F2M and VTL are maximum comparison levels for respiratory rate and tidal volume respectively. It should be noted that "tidal volume" used in the above equations may be the data provided by the ventilator as the set tidal volume on the ventilator (VTS), or maybe adjusted later based on the new calculated value of optimal tidal volume. Also, in ventilation assist modes that all breaths are triggered by the patient 10 such as pressure support mode, FIN may need to be defined at a higher level such as 0.75xF1. [00113] In the next step at 288, the required tidal volume is calculated as: tidal volume = MV/Fl [00114] In the next step, 290, the minimum allowed tidal volume and a comparison level 15 for minute ventilation maybe defined as: VTMIN = 2xVD +VED VREQ = 0.85xMV [00115] In the above example equations, VTMIN is the minimum allowed tidal volume, and VREQ is a comparison value for minute ventilation. 20 [00116] In the next step, 292, the calculated tidal volume in step 288 is compared to VTMIN and VMAX, and if it is outside this range, its value is adjusted. In the step that follows at 294, the total required peak inspiratory pressure in the pressure control/assist modes is calculated as: 36 Peak Inspiratory Pressure = [tidal volume/COMP] + PEEP [00117] Then control passes to step 296 in which the calculated peak inspiratory pressure is compared to a maximum allowed pressure which may be defined as (PMAX -8 cm H 2 0) and a minimum level that may be defined as PMIN = PEEP + 5 cm H 2 0. If the peak 5 inspiratory pressure is not within this range, its value is adjusted at step 296. [00118] At the next step at 298, the comparison levels for tidal volume, VTM and VTL, which were defined in step 286, are redefined preferably in the pressure control/assist modes of the ventilator based on the new calculated value of the tidal volume by using the following example equations: 10 VTM = 0.7xtidal volume VTL = 1.6xtidal volume [00119] At the step 300 that follows next, the spontaneous breathing rate, FSP, and the measured tidal volume, VTMS, are simultaneously examined. If FSP is higher than or equal to F2M and VTMS is lower than VTM, then the possibility of dyspnea is detected 15 and a warning message is generated at step 302 and control passes to step 318 which will be described later. However, if at step 300, FSP is not found to be too high with VTMS being too low, the next step at 304 is performed. At this step, measured tidal volume, VTMS, is compared to VTM. If VTMS is less than VTM, at step 306, the possibility of apnea is detected, a warning message is generated, and then control passes to step 324 20 which will be described later. [00120] However, if at step 304, VTMS is not found to be less than VTM, the next step at 308 is performed in which FSP is compared to F2M. If FSP is higher than or equal to F2M, then rapid breathing is detected at step 310, a warning message is generated, and 37 control passes to step 318. However, if at step 308, FSP is not found to be too high, the next step at 312 is performed in which measured tidal volume, VTMS, is compared to VTL. If VTMS is higher than or equal to VTL, a warning message is generated at the next step, 314, and program transfers to step 318. If at step 312, VTMS is found to be less than 5 VTL, then step 316 is performed in which multiple conditions are checked. Those conditions may be the following: Is FSP greater than FIN and less than F2M? Is FIO less than a predefined value (e.g. 0.5)? Is PEEP less than a predefined level (e.g. 6 cm H20)? 10 Is PaCO2 less than a predefined value (e.g. 53 mmHg)?Is SPO2 greater than or equal to a minimum safe value (e.g. 0.9)? [00121] If the answers to all or selected ones among the above questions are yes at step 316 (for example for more stable patients, it may be sufficient that only the first condition be checked) then at step 328 that follows, weaning is recommended to be started, or 15 continued if started already, and a message is generated to convey the recommendation to the clinician. Next, at step 330, recommendation is made to reduce controlled level of ventilation by a certain predefined percentage (e.g. 15% to 20%), and control passes to step 332. Reduction of the controlled level of ventilation may be done in different ways. For example, the minute ventilation supplied by the ventilator may be reduced as compared to 20 the optimal required minute ventilation calculated by the program by a prescribed percentage. Or, as another example, in the pressure support mode, the level of pressure support supplied by the ventilator may be reduced by a certain percentage (e.g. 15% to 20%) as compared to the required peak inspiratory pressure computed by the program.

38 [00122] At step 332, the optimal ventilatory parameters for the patient and the messages generated by the system are sent to display. If the invention is used to control the mechanical ventilator automatically, the required outputs are sent to the ventilator to control its outputs at this step. It should be noted that in the automatic weaning mode, 5 while the output signal to the ventilator for controlling the level of ventilation such as pressure support is reduced periodically, but the control signals for FIO and PEEP are adjusted only according to the calculated required values of these outputs and are not subjected to any reduction due to weaning. [00123] In the next step at 334, the system is instructed to wait for a predetermined period 10 of time if it is used to control the mechanical ventilator automatically, and after the wait time is over, control passes to step 200 at the start of the program and continues again. Otherwise, if the invention is not used to control the ventilator automatically, it stops at step 334 until it is restarted by the human operator. [00124] Back to step 316, if the necessary conditions for weaning are not satisfied, then 15 the next step at 318 is performed. At step 318, measured minute ventilation is compared to a minimum required level, VREQ, which was defined in step 290. If measured ventilation is lower than VREQ, possibility of apnea is detected at step 320, a warning message is generated, and control passes to step 322. But if at step 318, measured ventilation is not found to be low, then step 320 is not performed and control is transferred 20 to step 322. [00125] At step 322, the following conditions are checked: Is PaCo 2 greater than or equal to a predefined high value (e.g. 53 mmHg)? 39 Is SPO2 less than or equal to a predefined low value (e.g. 0.86)? Is the spontaneous breathing rate too low (e.g. below FIN)? [00126] If the answer to any of the above questions at step 322 is yes, then at the next step at 324, a message is generated that it is too early to start weaning, and if already started, 5 weaning should be stopped and the patient should be switched back to full ventilatory support (e.g. assist control), and program transfers to step 332. However, if at step 322, the answers to all questions are no, then control passes to step 326 in which a message is generated that weaning should not be started, but if it has already begun, it may continue with increased controlled ventilation (e.g. raised to the previous higher level), and then 10 program passes to step 332 (if the amount of ventilation checked at step 318 was not low, controlled ventilation may not need to be increased at step 326 if measured tidal volume is higher than the acceptable range). [00127] In the automatic mode if breaths are patient triggered, in addition to the above described procedure, the system also watches for prolonged apnea, and if no breath is 15 triggered by the patient for a predefined period of time (e.g. 25 seconds), it automatically switches back to mandatory breathing with full ventilatory support. [00128] It should be noted, that many of the constant parameters in the equations described above were examples for use in the treatment of adult patients which may be modified for different patients. Also, if the invention is used for pediatric or neonatal 20 treatments, many of the constant parameters will need to be changed. [00129] With the foregoing apparatus and processes in mind, various other embodiments of methods are possible within the scope of the invention. One such embodiment is a method 500 illustrated in the process flow diagram of FIG. 5. This is a general application 40 method for optimizing mechanical ventilation of a patient. The method begins at step 502, in which patient input data representing RES, COMP and WEIGHT is received, for example, at the input terminals of a processor such as computer 12. In the next step 504, input data representing patient oxygen level P02 is received, for example, from a pulse 5 oximeter or other transducing source. In the next step 506, additional input data is received. This input data may include FSP, VTMS, FIO, and PEEP, and may be received directly from a mechanical ventilator such as ventilator 10. [00130] The next three steps are computational steps, preferably performed automatically by a digital processor executing algorithms according to the invention. In step 508, optimal 10 ventilation level and optimal respiratory rate are determined based on all or a portion of the patient input data (RES, COMP, and WEIGHT) that was received in step 502. In the next step 510, a level of controlled ventilation is determined for the patient based on FSP, VTMS, the optimal ventilation level, and the optimal respiratory rate. In the third computational step 512, the method determines required levels of FIO and PEEP based on 15 P02 data received in step 504 and on FIO and PEEP data received in step 506. In the final step 514, one or more output signals are generated. These outputs may represent the required levels of FIO, PEEP, ventilation, respiratory rate, or the controlled ventilation needed for a next breath of the patient. [00131] FIG. 6 illustrates another generalized method according to the invention. This 20 method 600 may be practiced to determine whether weaning is appropriate for a patient, and if so, to provide a controlled way to safely wean the patient from reliance on a mechanical ventilator.

41 [00132] Method 600 begins at step 602, which includes providing patient input data representing RES and COMP. This data is provided, for example, to a computing system executing the control algorithms of the present invention. At the next step 604, additional patient input data indicative of the patient's WEIGHT is provided. This data may be 5 patient's ideal body weight, height, ventilation level at rest, or any other data that may be used as indicative of patient's ideal body weight by those skilled in the art. In the next step 606, data for the patient's oxygen level is provided. In the next step 608 patient input data representing VTMS and FSP is provided, and in step 610, patient input data representing PEEP is provided. Patient data provided in steps 602-610 may originate from one or more 10 individual transducers connected to the patient, from direct outputs received from a mechanical ventilator, or from a control circuit that derives the patient data from transducers, ventilator outputs, or user inputs (the data indicative of WEIGHT is preferably stored in software). [00133] A calculation step 612 is next in the process sequence. In step 612, an optimal 15 ventilation and an optimal respiratory rate are determined for the patient, based on data provided in steps 602 & 604. Next, in step 614, a decision is made whether to start weaning, or whether to continue weaning, if weaning has already started. If weaning is to start or continue, step 614 also determines a controlled ventilation level based on data provided in step 608 and also on results determined in step 612. Finally, in step 616, a 20 control signal is provided to the ventilator to automatically control a next breath of the patient. The control signal may be based on data from step 614. [00134] There has been described a method and apparatus that can be used for automatic respiratory control and weaning of patients on mechanical ventilation as well as a decision 42 support system in the treatment of such patients. Those skilled in the art appreciate modifications to the specific parameters described herein that can be made without departing from the spirit of the invention, and such modifications are included in the invention. This invention can be embodied in other specific forms without departing from 5 the spirit or essential attributes thereof, and accordingly, the invention is not limited to the foregoing preferred embodiments and reference should be made to the appended claims rather than to the foregoing specification as indicating the scope of the invention.

Claims

1. A method encoded on a data storage medium as executable software for optimizing mechanical ventilation of a patient, the method comprising steps of: 5 (a) receiving patient input data representing respiratory airway resistance (RES), respiratory compliance (COMP), and data indicative of patient's ideal body weight (WEIGHT); (b) receiving data representing patient oxygen level (P02); (c) receiving input data representing measured spontaneous breathing rate 10 (FSP), tidal volume (VTMS), inspired oxygen fraction (FIO), and positive end-expiratory pressure (PEEP); (d) determining optimal ventilation level and optimal respiratory rate for the patient based on data received in step (a); (e) determining a level of controlled ventilation for the patient based on the 15 FSP, the VTMS, the optimal ventilation level, and the optimal respiratory rate; (f) determining required levels of FIO and PEEP based on the patient oxygen level data received in step (b) and the patient FIO and PEEP data received in step (c); and (g) generating outputs representing the required levels of FIO, PEEP, and 20 the controlled ventilation for a next breath of the patient; the steps performed by a processor executing the software. 44

2. The method of claim 1 wherein step (e) further comprises determining whether to start or continue weaning the patient based on the FSP, the VTMS, the optimal ventilation level, and the optimal respiratory rate, and if so, determining the level of controlled ventilation for optimal weaning. 5

3. The method of claim 1 wherein the optimal respiratory rate is computed to minimize respiratory work rate.

4. The method of claim 3 wherein data received in step (a) includes data 10 representing patient body temperature (TEMP).

5. The method of claim 4 wherein data representing inspiratory to expiratory time ratio (TI/TE) is provided in step (c). 15

6. The method of claim 4 wherein the optimal ventilation level, MV, in liters/minute is calculated as: MV = V'+ a x V' x (TEMP - 37) for TEMP > 37, MV = V' for TEMP < 37, where V' = p x WEIGHT, WEIGHT is in Kg, TEMP is in degrees C, and a and P are 20 constants.

7. The method of claim 6 wherein the optimal respiratory rate is calculated as: 45 2 ALV - K'xVD + I(K'xVD)2 +4xKxRES xr12 X(60 )xVD FI=60x2 x RES XI-12 x VD where F 1 is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - F1 x VD. 5

8. The method of claim 5 further comprising adjusting the TI/TE ratio so that expiration time TE = 0.5/fmax, where fmax is a maximum allowed respiratory rate calculated as: fmax = 1/ (5 x RES x COMP). 10

9. The method of claim 1 wherein step (b) further comprises receiving data representing patient carbon dioxide level (PCO2) and wherein step (d) further comprises determining optimal ventilation level and optimal respiratory rate for the patient based on data received in step (a) and step (b). 15

10. The method of claim 9 wherein the optimal respiratory rate is computed to minimize respiratory work rate.

11. The method of claim 10 wherein the optimal ventilation comprises optimal alveolar ventilation, VALV, which is calculated as: 20 VALV = (VAO + VAC) x VALV(rest) 46 where VAO = 4.72 x 10- 9 x (104 - PaO2) 4 - 9 for PaO2< 104 mm Hg, and VAO = 0 for PaO2> 104 mm Hg, VAC = C1 x PaCO2 - C2 for PaCO2 greater than a predefined value and VAC =0 otherwise, and VALV(rest) = K x WEIGHT, where VALV and VALV(rest) are alveolar ventilation and alveolar ventilation at rest in liters/minute respectively, PaO2 5 and PaCO2 are partial pressures of oxygen and carbon dioxide in patient's arterial blood in mmHg respectively, and C1, C2, and K are constants.

12. A method in accordance with claim 11 wherein the optimal respiratory rate is calculated as: 2 ALV r K'xVD+ I(K'xVD)2 +4xKxRES xI2 X 60V)xVD 10 F=60x 2x RES xI12 x VD where Fl is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - Fl x VD. 15

13. The method of claim 1 wherein P02 is set equal to measured arterial oxygen saturation of the patient (SPO2), and wherein FIO is computed by using a sequential procedure, with SPO2 compared to predefined threshold levels successively and FIO adjusted accordingly. 20

14. The method of claim 13 wherein the sequential procedure comprises the following steps: 47 comparing SPO2 with a high threshold value; if SPO2 is higher than or equal to the high threshold value, reducing FIO down to a predefined low value FRI but not lower than FRI as: new FIO = FRI + (FIO-FR1) x K" 5 where K" is a factor less than 1; if SPO2 is lower than the high threshold value, comparing SPO2 with a lower second threshold value, and if it is higher than or equal to the lower second threshold value, reducing FIO down to a predefined value FR2 but not lower than FR2 as: new FIO = FR2 + (FIO-FR2)xK"; 10 if SPO2 is lower than the second threshold value, comparing it with a lower third threshold value, and if SPO2 is higher than or equal to the third threshold value, raising FIO to a predefined value FR3 if it is lower than FR3; if SPO2 is lower than the third threshold value, comparing it with a lower fourth threshold value, and if it is higher than or equal to the fourth threshold value, raising

15 FIO to a predefined value FR4 if it is lower than FR4; and if SPO2 is lower than the fourth threshold value, comparing FIO with a predefined high value, and if it is lower than the predefined high value, raising FIO to the predefined high value. 20 15. The method of claim 14 wherein PEEP is increased incrementally if SPG2 is found to be lower than the fourth threshold value and if a predefined minimum time has elapsed since a most recent adjustment in PEEP. 48

16. The method of claim 15, further comprising determining a ratio of PEEP to FIO (RATIO); comparing RATIO to predefined minimum and maximum values for the ratio; 5 increasing PEEP if RATIO is lower than the minimum value and a predefined minimum time has elapsed since a most recent adjustment in PEEP; and decreasing PEEP if RATIO exceeds the maximum value to bring RATIO lower than or equal to the maximum value. 10

17. The method of claim 2 further comprising comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and if FSP and VTMS are both within their respective acceptance ranges, 15 determining that weaning should start or continue with a lowered level of controlled ventilation.

18. The method of claim 2 further comprising comparing FSP to an FSP acceptance range based on the determined 20 optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and 49 if FSP exceeds a maximum of the FSP acceptance range, if VTMS is less than a maximum of the VTMS acceptance range, and if P02 exceeds a predefined value, determining that weaning should continue with an increased level of controlled ventilation. 5

19. The method of claim 2 wherein step (b) further comprises receiving data representing patient carbon dioxide level (PCO2); wherein step (d) further comprises determining optimal ventilation level and optimal respiratory rate for the patient based on data received in step (a) and step (b); and further comprising comparing FSP to an FSP acceptance range based on the 10 determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with lowered level of controlled ventilation if started already, if FSP and VTMS are both within their respective acceptance ranges. 15

20. The method of claim 2 wherein step (b) further comprises receiving data representing patient carbon dioxide level (PCO2); wherein step (d) further comprises determining optimal ventilation level and optimal respiratory rate for the patient based on data received in step (a) and step (b); and 20 further comprising comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and 50 determining that weaning should start, or should continue with a lowered level of controlled ventilation if started already, if FSP and VTMS are both within their respective acceptance ranges, if P02 exceeds a predefined value, and if PCO2 is below a predefined level. 5

21. The method of claim 20 further comprising determining that weaning should start, or should continue with a lowered level of controlled ventilation if already started, if required FIO is below a predefined value and if required PEEP is also below a predefined value. 10

22. The method of claim 1 implemented on a digital computer wherein one or more of the data in steps (a) through (c) is provided manually to the computer through a user interface. 15

23. The method of claim 1 implemented on a digital processor wherein the input data is provided to the processor automatically.

24. An apparatus for optimizing mechanical ventilation of a patient, comprising: 20 a computing system; digital readable memory coupled to the computing system; and transducers providing patient input signals to the computing system representing respiratory airway resistance (RES), respiratory compliance (COMP), and 51 ventilation data representing patient's spontaneous breathing rate (FSP), and measured tidal volume (VTMS); wherein the computing system executing a program stored in the memory determines output data representing optimal ventilation level and optimal respiratory rate 5 of the patient based on data indicative of patient's ideal body weight (WEIGHT) stored in memory and data representing RES and COMP, and provides output data representing optimal ventilation and optimal respiratory rate and a controlled level of mechanical ventilation based on the optimal ventilation data, the optimal respiratory rate data, FSP, and VTMS. 10

25. The apparatus of claim 24 further comprising a transducer providing input signal representing patient's measured oxygen level (P02) to the computing system.

26. The apparatus of claim 25 wherein the transducers include a pulse oximeter 15 providing the P02 input signal and one or more sensors providing the RES and COMP signals.

27. The apparatus of claim 26 further comprising a transducer providing input signal representing measured carbon dioxide level (PCO2) of the patient and wherein the 20 computing system executing the program further determines, based on P02 and PCO2, required levels of ventilation and respiratory rate of the patient. 52

28. The apparatus of claim 27 wherein the transducers include an end-tidal carbon dioxide analyzer for providing the PCO2 patient input signal.

29. The apparatus of claim 25 wherein the transducers further provide to the 5 computing system patient input signals representing positive end-expiratory pressure (PEEP) and inspired oxygen fraction (FIO) and wherein the computing system executing the program determines output data representing required PEEP and required FIO and supplies the required PEEP and the required FIO to the mechanical ventilator. 10

30. A method for automatically controlling a mechanical ventilator to wean a patient from mechanical ventilation, comprising the steps of: (a) providing patient data representing respiratory airway resistance (RES) and respiratory compliance (COMP); (b) providing patient data indicative of ideal body weight (WEIGHT); 15 (c) providing patient data representing measured oxygen level (P02); (d) providing patient data representing tidal volume (VTMS) and spontaneous breathing rate (FSP); (e) providing patient data representing positive end-expiratory pressure (PEEP); (f) determining based on data provided in steps (a) and (b), optimal ventilation and 20 optimal respiratory rate of the patient; (g) determining whether weaning should start or continue and a level of controlled mechanical ventilation based on the optimal ventilation, the optimal respiratory rate, and patient data provided in step (d); and 53 (h) providing a control signal representing a controlled ventilation level based on data from step (g) and supplying the control signal to the mechanical ventilator to control it automatically for a next breath of the patient. 5

31. The method of claim 30 wherein data received in step (b) includes data representing patient body temperature (TEMP).

32. The method of claim 30 wherein step (c) further comprises providing data representing patient carbon dioxide level (PCO2) and wherein data provided in steps (a), 10 (b), and (c) are used in step (f) to determine the optimal ventilation and the optimal respiratory rate of the patient.

33. The method of claim 32 further comprising providing patient input data representing inspired fraction of oxygen (FIG), and wherein the FIO data, data in step (c), 15 and data representing PEEP are also used in step (g) to determine whether weaning should begin.

34. The method of claim 31 wherein the optimal ventilation, MV, in liters/minute is calculated in step (f) as: 20 MV = V'+ a x V'x (TEMP - 37) for TEMP > 37, MV = V' for TEMP < 37, where V' = P x WEIGHT, WEIGHT is in Kg, TEMP is in degrees C, and a and P are constants. 54

35. The method of claim 34 wherein the optimal respiratory rate is calculated as: 2 ALV r K'xVD+ I(K'xVD)2 +4xKxRES xI2 X 60V)xVD F=60x 2x RES xI12 x VD 5 where F 1 is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - F1 x VD.

36. The method of claim 35 wherein VD is calculated as: VD = 0.0026 x 10 WEIGHT.

37. The method of claim 32 wherein the optimal ventilation comprises optimal alveolar ventilation, VALV, which is calculated as: VALV = (VAO + VAC) x VALV(rest) 15 where VAO = 4.72 x 10- 9 x (104 - PaO2) 4 - 9 for PaO2< 104 mm Hg, and VAO = 0 for PaO2> 104 mm Hg, VAC = C1 x PaCO2 - C2 for PaCO2 greater than a predefined value and VAC =0 otherwise, and VALV(rest) = K x WEIGHT, where VALV and VALV(rest) are alveolar ventilation and alveolar ventilation at rest in liters/minute respectively, PaO2 and PaCO2 are partial pressures of oxygen and carbon dioxide in patient's arterial blood in 20 mmHg respectively, and Cl, C2, and K are constants. 55

38. The method of claim 37 wherein PaCO2 is obtained from: PaCO2 = PCO2 + K1, where PCO2 is patient's end-tidal pressure of carbon dioxide and K1 is a constant.

39. A method in accordance with claim 37 wherein PaO2 is obtained as: 5 Pao2 = lnl - (SP02)05 +C3 0.046 where SPO2 is patient's arterial oxygen saturation measured by pulse oximetry and C3 is a shifting constant that depends on patient blood pH level.

40. A method in accordance with claim 37 wherein the optimal respiratory rate 10 is calculated as: 2 VALV 1 K'xVD+ (K'xVD)2+4xK'xRESxH2 x( )xVD !F1=60x 60 F1J= 60x 2xRESx1- 2 xVD where F1 is the optimal respiratory rate in breaths/minute, K' is respiratory elastance (reciprocal of COMP) in cmH 2 O/liter, RES is in cmH 2 O/liter/second, VD is respiratory dead space in liters, and VALV = MV - F1 x VD. 15

41. The method of claim 40 wherein VD is calculated as: VD = 0.1698x(VALV/60) + 0.1587.

42. The method of claim 30 further comprising 20 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; 56 comparing VTMS to a VTMS acceptance range; and determining that weaning should start or continue with a lowered level of controlled ventilation if FSP and VTMS are both within their respective acceptance ranges. 5

43. The method of claim 30 further comprising comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should continue with an increased level of 10 controlled ventilation if VTMS is below a maximum value of the VTMS acceptance range, if P02 exceeds a predefined value, and if FSP exceeds a maximum value of the FSP acceptance range.

44. The method of claim 32 further comprising 15 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with lowered level of controlled ventilation if started already, if FSP and VTMS are both within their 20 respective acceptance ranges.

45. The method of claim 32 further comprising 57 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should continue with increased level of controlled 5 ventilation if VTMS is lower than a maximum value of the VTMS acceptance range, if P02 exceeds a predefined value, if PCO2 is below a predefined value, and if FSP exceeds a maximum value of the FSP acceptance range.

46. The method of claim 32 further comprising 10 comparing FSP to an FSP acceptance range based on the determined optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with a lowered level of controlled ventilation if started already, if FSP and VTMS are both within their 15 respective acceptance ranges, if P02 exceeds a predefined value, and if PCO2 is below a predefined value.

47. The method of claim 33 further comprising comparing FSP to an FSP acceptance range based on the determined 20 optimal respiratory rate; comparing VTMS to a VTMS acceptance range; and determining that weaning should start, or should continue with a lowered level of controlled ventilation if started already, if FSP and VTMS are both within their 58 respective acceptance ranges, if P02 exceeds a predefined value, if PCO2 is below a predefined value, if FIO is lower than a predefined value, and if PEEP is lower than a predefined value.

48. The method of claim 22 comprising an advisory decision support system, 5 wherein the generated outputs in step (g) cause instructions for a user.

49. The method of claim 1 wherein the outputs generated in step (g) are signals that 10 are supplied to a mechanical ventilator to control it automatically.

50. The method of claim 2 wherein the outputs generated in step (g) are signals that are supplied to a mechanical ventilator to control it automatically. 15

51. A method encoded on a data storage medium as executable software for optimizing mechanical ventilation of a patient as herein described with reference to any one or more of the accompanying drawings.

52. An apparatus for optimizing mechanical ventilation of a patient as 20 herein described with reference to any one or more of the accompanying drawings.

53. A method for automatically controlling a mechanical ventilator as herein described with reference to any one or more of the accompanying drawings.