Abstract:
The invention relates to a device to determine effective pulmonary blood flow (PBF) by means of partial CO 2  rebreathing. The device is characterized in that it comprises an endotracheal tube whose conduit leading from the patient to the respirator is divided up into two lines between a controllabe three-way valve ( 4 ) and a Y-piece; one line forms a larger dead area ( 6 ) for CO 2  rebreathing whereby, in order to measure CO 2  elimination and end expiratory partial CO 2  pressure, a CO 2  sensor ( 3 ) and a respiration flow sensor ( 1 ) are provided on the endotracheal tube of the patient. The calculation of effective pulmonary blood flow is provided by a microprocessor/controller ( 7 ) which also controls the three-way valve ( 4 ) which provides the switching between both lines.

Description:
REFERENCE TO RELATED APPLICATIONS  
       [0001]    This is a continuation-in-part of Ser. No. 10/097,064, filed Mar. 13, 2002, which is a continuation of Ser. No. 09/638,996, filed Aug. 14, 2000, now U.S. Pat. No. 6,394,962, which is a continuation of Ser. No. 09/269,458, filed Apr. 23, 1999, now U.S. Pat. No. 6,106,480. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    The invention relates to an arrangement for the determination of the effective pulmonary blood flow.  
           [0003]    From the paper Steinhart, C. M., Burch, K. D., Bruno, S., Parker, D. H.: Noninvasive determination of effective (nonshunted) pulmonary blood flow in normal and injured lungs, Crit. Care Med., 1989, Vol. 17, No. 4, pp. 349-353 the Multiple-Inert-Gas method with rebreathing of helium, acetylene and carbon monoxide in oxygen and nitrogen from a respiratory bag is known. A disadvantage of this measurement is the relatively great effort to prepare the gas mixtures for rebreathing, the demand for special measuring instruments that can measure the concentrations of gases in the breathed air or the breathing flow, respectively, and the necessity of a person to connect the respiratory bag to the patient and maintain it. For those reasons the measurement of the effective pulmonary blood flow can only be executed by specialists and is for research purposes in almost all cases.  
           [0004]    Further, from the paper by Inman, M. D., Hughson, R. L., and Jones, N. L.: Comparison of cardiac output during exercise by single-breath and CO 2  rebreathing methods, J. Appl. Physiol., Vol. 58, pp. 1372-1377, 1985, the total CO 2  rebreathing method and the so-called single-breath method are known. Disadvantages of these methods are distinct increases of CO 2  pressure in the arterial blood, as the CO 2  elimination is interrupted, and the impeding of the respiration. Other disadvantages are those of the Multiple-Inert-Gas method, namely the preparation of gas mixtures for rebreathing having certain CO 2  concentrations, the demand for special measuring instruments that can measure the concentrations of gases in the breathed air or the breathing flow, respectively, and the necessity of a person to connect the respiratory bag to the patient and maintain it.  
           [0005]    Another method known is a partial CO 2  rebreathing method (according to Gedeon, A., Forslund, L., Hedenstierna, G. and Romano, E.: a new method for noninvasive bedside determination of pulmonary blood flow, Med. &amp; Biol. Eng. &amp; Comp., 1980, Vol. 18, pp. 411-418) based on varying minute ventilation. Disadvantage of this method is the variation of the mean respiratory tract pressure and of the pressure at the end of expiration. Due to this variation of the respiratory tract pressure the pulmonary blood flow also varies and both the mechanical stability of the lungs and the gas exchange are impeded.  
           [0006]    From the paper by Capek, J. M. and Roy, R. J.: Noninvasive measurement of cardiac output using partial CO 2  rebreathiing; IEEE Transactions on Biomedical Engineering, 1988, Vol. 35, No. 9, pp. 653-661) the partial CO 2  rebreathing method with change of the dead space of the apparatus is known, which is performed using a mass spectrometer and special respiratory flow sensors at the endotracheal tube and can measure the total cardiac output. The change between two different dead spaces is performed by a PC-controlled electromagnetic valve. The partial expiration termination pressure and the CO 2  elimination are determined for the respiration by both dead spaces. The CO 2  partial pressure at the end of expiration is converted to the arterial CO 2  concentration and the total cardiac output can be calculated from the division of the CO 2  elimination difference by the arterial CO 2  concentration difference. A disadvantage of this method is the demand for apparatus for the measurement of the CO 2  concentration in the breathed air (mass spectrometer) and of the respiratory flow at the endotracheal tube (Fleisch pneumatocograph).  
           [0007]    It is the objective of this invention to describe a clinically practicable arrangement for noninvasive determination of the effective pulmonary blood flow whereby the effective pulmonary blood flow is the cardiac output minus the intrapulmonary shunt proportion. Only that portion of the cardiac output is intended to be determined which is available for gas exchange. This arrangement requires only little apparatus, does not essentially influence the respiratory schedule, and is capable of being automated.  
         SUMMARY OF THE INVENTION  
         [0008]    According to the invention, the problem is solved using features given by claim 1. The dependant subclaims give other useful developments and embodiments. The selected parameters, above all, made it possible for the first time to determine the effective pulmonary blood flow during respiration, i.e. only that portion of the cardiac output that is available for gas exchange,  
           [0009]    In the arrangement according to the invention, which is controlled by a microprocessor or a controller, the signals of a main stream CO 2  sensor and a respiratory flow sensor are detected. The main stream CO 2  sensor is intended for measurement of the CO 2  concentration of the respiratory air, the respiratory flow sensor for measurement of the respiratory flow (FIG. 1). The respiratory flow sensor is located between the endotracheal tube and the CO 2  sensor. There is a controllable 3-way valve between the endotracheal tube and the Y-fitting of the respirator. This valve is switched by the microprocessor or the controller so that the patient is respirated through a short or a long branch (so-called dead space) (FIG. 2).  
           [0010]    Measurements of the CO 2  elimination and expiration termination CO 2  partial pressure are first performed during respiration through the small dead space. This period lasts approx. 60 s, and is called non-rebreathing period. After this period during an inspiratory cycle the 3-way valve is switched so that the patient is respirated through the bigger dead space (long branch) and rebreathes a gas mixture that consists of his or her own expired air and fresh air from the respirator. Thus no separate CO 2  source for rebreathing is required. The time for switching the 3-way valve is derived from the absence of CO 2  in the inspiratory air. This causes no essential variation of the respiratory pressure. The subsequent period last approx. 30 s and is called rebreathing period. The CO 2  elimination and the expiration termination CO 2  partial pressure of this period are measured as mean values of each variable during a plateau that forms in the range of 15 to 30 s during this period (second half).  
           [0011]    The arrangement according to the invention creates the possibility to set the respiratory schedule of the patient in the respirator such that the maximum pulmonary blood flow is achieved with the lowest mean and expiration termination respiratory tract pressure. This lowers the risk of the patient to suffer from a barotrauma, i.e. lung damage due to increased airway pressure is avoided and, simultaneously, the oxygen supply to the organs is optimised. This solution also raises the possibility to monitor the haemodynamics of the patient noninvasively and to record it automatedly. If simultaneous measurements of the cardiac output are taken, the found solution makes it possible to measure the percentage of the non-breathed cardiac output (so-called intrapulmonary shunt) without the inspiratory oxygen concentration being increased and blood samples being required. 
       
    
    
     BRIEF DESCRIPTIONS OF THE DRAWINGS  
       [0012]    In the following, further details of the arrangement will be disclosed. By means of the accompanying drawing there are shown:  
         [0013]    [0013]FIG. 1 an arrangement of a microprocessor or a controller for the measurement of the effective pulmonary blood flow  
         [0014]    [0014]FIG. 2 an arrangement according to the invention with a microprocessor/controller and respirator  
         [0015]    [0015]FIG. 3 an example of a CO 2  concentration and respiratory flow plot taken with the arrangement according to the invention  
         [0016]    [0016]FIG. 4 an example of an expiration termination CO 2  partial pressure and CO 2  elimination plot together with the calculated pulmonary blood flow. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0017]    In FIG. 1, an arrangement of an microprocessor/controller for the measurement of the effective pulmonary blood flow that consists of four components is presented. The various components are connected with each other through cable and plug. According to FIG. 1 the system includes a microprocessor/controller  7  and an analog-digital-converter card  8  that registers and processes the CO 2  concentration and respiratory flow signals from the CO 2  sensor  3  or respiratory sensor  1 , respectively.  
         [0018]    In FIG. 2, a microprocessor- or controller-controlled arrangement for the measurement of the effective pulmonary blood flow is presented that consists of seven components, or less or more as desired. According to FIG. 2 the endotracheal tube of the patient is connected to one side of the respiratory flow sensor  1 . To the other side of the respiratory flow sensor  1 , a CO 2  cuvet  2  is connected. A CO 2  sensor  3  is inserted into the CO 2  cuvet  2 . A switchable 3-way valve  4  is connected to the other side of the CO 2  cuvet  2 . One of the outputs of the 3-way valve  4  is connected to a Y-fitting  5 , the other output is connected to the dead space  6  for rebreathing. A respirator and the dead space  6  for rebreathing are also connected to the Y-fitting  5 . The dead space  6  for rebreathing is about 200 ml, or less or more as desired, depending on the respiratory schedule of the patient. Alternatively, the dead space  6  may be adjustable in volume, typically from 50 to 15,000 ml. For example, the dead space  6  may be a highly flexible tube. A connection exists to the 3-way valve  4 , through which the inner diaphragm of the valve  4  can be moved by pressure or flow. The microprocessor/controller  7  controls the 3-way valve  4 , and senses and processes the CO 2  concentration and respiratory flow signals. The infrared CO 2  sensor  3  may be a mainstream or a sidestream sensor.  
         [0019]    In FIG. 3, the curves of the CO 2  concentration in the respiratory air and of the respiratory flow during a measurement are presented. In the expiration period CO 2  is expired through the endotracheal tube. The CO 2  concentration (FCO 2 ) of the expired air, which corresponds with the CO 2  partial pressure (PCO 2 ) of the air, increases with the expired volume and reaches a maximum at the end of expiration. The CO 2  partial pressure at this time, the so-called expiration termination CO 2  partial pressure (PetCO 2 ), approximately corresponds with the CO 2  partial pressure in the ventilated pulmonary capillaries. During the nonrebreathing period PetCO 2  values are measured that only just differ. During the rebreathing period part of the expired CO 2  is rebreathed. Therefore the behaviour of the CO 2  partial pressure in the breathing air modifies and PetCO 2  increases.  
         [0020]    In FIG. 4, the curves of the expiration termination CO 2  partial pressure corresponding with the maximum of the CO 2  concentration during expiration and of the CO 2  elimination per respiration during measurement using the arrangement according to the invention are given. The CO 2  elimination decreases during a partial CO 2  rebreathing and the expiration termination CO 2  partial pressure increases until a plateau has been reached, usually after approx. 15 s. The effective pulmonary blood flow is calculated from the four parameters given in FIG. 4, following the equation:  
       PBF   =             CO   2          (   NR   )       -       VCO   2          (   R   )         )         f        (         f   1          (       PetCO   2          (   R   )       )       ,       f   2          (       PetCO   2          (   NR   )       )       ,   Hb     )       ×     F   s                               
 
         [0021]    VCO 2 (NR) is meant to be CO 2  elimination, in ml/min, during the nonbreathing period measured as the mean value of the CO 2  elimination of complete respirations within 60 s until immediately before the beginning of the rebreathing period. The nonrebreathing period can take 60 s or longer or shorter. The nonrebreathing period can also be represented by the period immediately after the rebreathing period, i.e., after the 3-way valve ( 4 ) has been in the rebreathing position. The CO 2  elimination can be measured taking the variations of CO 2  stores in the lungs into account and compensating for that variation when the respiratory pattern is not regular, as, for instance, during spontaneous breathing or modes of ventilation that allow the patient to trigger the mechanical ventilation or to have spontaneous breaths superposed to breaths originated form the mechanical ventilator. PetCO 2 (R) is the expiration termination CO 2  partial pressure, in mmHg, in the respiratory air during the nonrebreathing period measured as the mean value of expiration termination CO 2  partial pressures of complete respirations within 60 s until immediately before the beginning of the rebreathing period.  
         [0022]    PetCO 2 (NR) is the expiration termination CO 2  partial pressure, in mmHg, in the respiratory air during the rebreathing period measured as the mean value of the expiration termination CO 2  partial pressures of complete respirations within 60 s until immediately before the beginning of the rebreathing period. The nonrebreathing period can take 60 s or longer or shorter. The partial pressures of complete respirations within 60 s until immediately before the beginning of the rebreathing period. The nonrebreathing period can take 60 s or longer or shorter. The nonrebreathing period can also be represented by the period immediately after the rebreathing period, i.e., after the 3-way valve ( 4 ) has been in the rebreathing position. The PetCO 2 (NR) can be estimated from a neural network or other filtering techniques if the values within the observation period are not constant.  
         [0023]    f 1  is a function to better approximate the PetCO 2  to the end-capillary CO 2  partial pressure (PcCO 2 ) during the nonrebreathing period. This function can represent: a) the simple sum of the difference between the CO 2  partial pressure in arterial blood (PaCO 2 ), as determined invasively; b) the estimation of the difference between PcCO 2  and PetCO 2  according to gas exchange models that use alveolar deadspace and/or functional residual capacity (FRC) values that have been measured or estimated by normograms; c) the combination between invasive determined PaCO 2  and gas exchange models.  
         [0024]    VCO 2 (R) is the CO 2  elimination, in ml/min, during the rebreathing period measured as the mean value of the CO 2  elimination of complete respirations within 15 to 30 s after the patient has begun to be respired through the big dead space  6 , i.e. after switching of the 3-way valve  4  into the rebreathing position. The rebreathing period can be extended to 60 s or longer, but can also be shortened to 25 s or less. The CO 2  elimination can be alternatively measured taking the variations of CO 2  stores in the lungs into account and compensating for that variation when the respiratory pattern is not regular, as, for instance, during spontaneous breathing or modes of ventilation that allow the patient to trigger the mechanical ventilation or to have spontaneous breaths superposed to breaths originated from the mechanical ventilator. Alternatively, VCO 2 (R) can be measured form the first breath in the rebreathing period taking the FRC and the variation of breath-to-breath PetCO 2  or PcCO 2  differences into account in a gas exchange model. Also, curve fitting procedures can be applied to the breath-by-breath VCO 2  values measured or estimated in the rebreathing period in order to improve the estimation of VCO 2 (R).  
         [0025]    PetCO 2 (R) is the expiration termination CO 2  partial pressure, in mmHg, in the respiratory air during the rebreathing period measured as the mean value of the expiration termination CO 2  partial pressures of complete respirations within 15 to 30 s after the patient has begun to be respired through the big dead space  6  (after switching of the 3-way valve  4  into the rebreathing position). The rebreathing period can be extended to 60 s or longer, but can also be shortened to 25 s or less. The time window of 15 to 30 s for taking the average value can be shortened or extended appropriately. Alternatively, PetCO 2  values can be entered into a curve fitting procedure to estimate PetCO 2  at equilibrium.  
         [0026]    f 2  is a function to better approximate the PetCO 2  to the end-capillary CO 2  partial pressure (PcCO 2 ) during the rebreathing period. This function represents the estimation of the difference between PcCO 2  and PetCO 2  in the rebreathing period using gas exchange models that take the alveolar deadspace and/or the FRC measured or calculated by normograms into account. Such models may use or not the breath-by-breath VCO 2  into account. Estimated PcCO 2  values can be entered into a curve fitting procedure to estimate PcCO 2  at equilibrium.  
         [0027]    Finally, the function f(f 1 (PetCO 2 (R), f 2 (PetCO 2 (NR), Hb) is the standardized CO 2  dissociation curve in blood. By this function which has already been described in the literature (McHardy, G. J. R.: The relationship between the differences in pressure and concentration in arterial and venous blood, Cli. Sci., 1967 32, pp. 299-309), from the PetCO 2 (R) and PetCO 2 (NR) values and using also the haemoglobin concentration (Hb, g/dl), which has to be determined with a different device in a blood sample of the patient, the difference of the CO 2  concentrations (ΔCCO 2 , % by volume −ml/100 ml of blood) in the pulmonary capillary blood between the rebreathing and nonrebreathing periods is calculated using the following equation:  
         f(PetCO 2 (R), PetCO 2 (NR), Hb)=ΔCCO 2 =11.02×(PetCO 2 (R) 0.396 −PetCO 2 (NR) 0.396 )− 
         0.015×(15−Hb)×(PetCO 2 (R)−PetCO 2 (NR)) 
         [0028]    Further, Fs is a scale factor for the representation of the effective pulmonary blood flow, in 1/min. Fs is defined to be 10.  
         [0029]    From the calculation the effective pulmonary blood flow, PBF, in 1/min, is obtained.