System for continuous measuring, recording and monitoring of the splanchnic tissue perfusion and the pulmonary physiological dead space, and use thereof

Abstract

The present invention relates to a new system for measuring, recording and monitoring the splanchnic tissue perfusion and the pulmonary physiological dead space in an automated way, both continuously and intermittently, and in real time, which is easy to manage and generates information easy to interpret. Said system comprises at least four measuring devices of medical parameters, connected to a device receiving, converting, storing, integrating, processing, and allowing the management and display of the data recorded in the measurements and the parameters estimated by the same. For this purpose, said device comprises a specific computer program of estimation of parameters related to the measurement of the splanchnic tissue perfusion and the pulmonary physiological dead space, from the data derived from the measuring devices. Likewise, the present invention is related to the use of a device for measuring, recording and monitoring of the splanchnic tissue perfusion and the pulmonary physiological dead space.

Claims

1. A system for measuring, recording, and monitoring splanchnic tissue perfusion and pulmonary physiological dead space, comprising: a) a continuous measuring device of carbonic anhydride pressure in a lumen of a digestive tube (PgCO.sub.2), comprising a probe configured to be positioned nasogastrically or recto-sigmoidally, the probe type for measuring the CO.sub.2 being selected from the group consisting of: a probe with a terminal silicone balloon permeable to CO.sub.2 that is filled with air, which measures CO.sub.2 by extraction, analysis, and reintroduction of a gas sample in the balloon every 10 minutes and automatedly; and a probe with a optic fiber sensor in its patient end, measuring CO.sub.2 in situ and continuously; b) a standard intermittent measuring device of the arterial pH, pHa, and CO.sub.2 arterial pressure, PaCO.sub.2, of a blood sample; c) a continuous measuring device of CO.sub.2 transcutaneous pressure, PtcCO.sub.2, consisting of a transcutaneous capnography sensor; d) a continuous measuring device of end-expiratory CO.sub.2, EtCO.sub.2, consisting of an expiratory air standard capnograph, the probe or sensor of which is connected in a patient's airway; e) connections between the measuring devices (a, b, c and d); and f) a device of reception, conversion, storage, integration, processing, management, and display of the data recorded in the measuring devices (a, b, c and d) comprising: a computer program module (f1) of reception and storage of the measurements performed with the measuring devices (a, b, c and d), a second specific module (f2) of conversion-normalization of data received and stored in the reception and storage module (f1), a third module (f3) of processing and integration of the data converted-normalized by the conversion-normalization module (f2), a fourth program module (f4) of storage of the data processed by the processing module (f3); a fifth specific module (f5) of automated, continuous, and real time estimate of the following parameters related to the measurement of the splanchnic tissue perfusion and the pulmonary physiological dead space, the data being derived from the fourth storage module (f4) that was previously processed by the processing module (f3): intramucosal pH in the digestive tube, pHi, which is estimated as a function of the pHa and the PaCO.sub.2 obtained by the device (b), and the PgCO.sub.2 obtained by the device (a); difference of gastric-arterial or systemic-regional pH, pHgap, which is estimated as a function of the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); standard intramucosal pH, pHis, which is estimated as a function of the normal arterial pH, the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b), the normal arterial pH being 7.4; gastric-arterial CO.sub.2 gradient in percentage, % CO.sub.2gap, which is estimated as a function of the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); difference of gastric-transcutaneous pH, pHgap(tc), which is estimated as a function of the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); transcutaneous standard intramucosal pH, pHis(tc), which is estimated as a function of the normal arterial pH (7.4), the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); gastric-transcutaneous CO.sub.2 gradient in percentage, % CO.sub.2gap(tc), which is estimated as a function of the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); difference of arterial-expiratory pH, pHgap(a-et), which is estimated as a function of the PaCO.sub.2 obtained by the device (b) and the EtCO.sub.2 obtained by the device (d); arterial-expiratory standard pH, pHs(a-et), which is estimated as a function of the normal arterial pH (7.4), the PaCO.sub.2 obtained by the device (b) and the EtCO.sub.2 obtained by the device (d); pulmonary physiological dead space, V.sub.D/V.sub.T, which is estimated as a function of the PaCO.sub.2 obtained by the device (b) and the PECO.sub.2 obtained by the device (d); transcutaneous pulmonary physiological dead space, V.sub.D/V.sub.T(tc), which is estimated as a function of the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d); difference of transcutaneous-expiratory pH, pHgap(tc-et), which is estimated as a function of the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d); and transcutaneous-expiratory standard pH, pHs(tc-et), which is estimated as a function of the normal arterial pH, the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d); an input interface (f6) allowing a user to enter commands in the fifth specific module (f5) of parameter estimation; an output interface (f7) allowing the user to view in real time the information input in the device (f) and the output from the fifth specific module (f5), in both tabular and graphic form; a module (f8) of recording the parameters estimated by the fifth specific module (f5), for the subsequent recovery and analysis thereof; and an alarm (f9) for checking the operation of the device (f) and the connections (e), to detect problems in operating and receiving measurements, and parameters programmable alarm (measurement values exceeded) by the fifth specific module (f5), independent of the one existing in the measuring equipment.

2. The system according to claim 1, wherein the probe of the device (a) is configured to be in the stomach or in the recto-sigmoidal colon.

3. The system according to claim 2, wherein the transcutaneous capnography sensor of the device (c) is a transcutaneous oxycapnograph for the earlobe, which can be used in patients of any age.

4. The system according to claim 2, wherein the computer program (f5) of parameter estimates performs the following estimates: pHi, from the difference between the pHa obtained by the device (b) and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); pHgap, from the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); pHis, from the difference between the normal arterial pH and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b), the normal arterial pH being 7.4, % CO.sub.2gap, from the ratio between: the difference between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b), and the PgCO.sub.2, multiplied by 100; % CO.sub.2gap(tc), from the ratio between: the difference between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c), and the PgCO.sub.2, multiplied by 100; pHgap(tc), from the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); pHis(tc), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); pHgap(a-et), from the logarithm of the ratio between the PaCO.sub.2 measured with the device (b) and the EtCO.sub.2 obtained by the device (d); pHs(a-et), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PaCO.sub.2 measured by the device (b) and the EtCO.sub.2 obtained by the device (d); V.sub.D/V.sub.T(tc), from the ratio between: the difference between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d), and the PtcCO.sub.2; pHgap(tc-et), from the logarithm of the ratio between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d); and pHs(tc-et), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d).

5. The system according to claim 2, wherein the device (d) further measures the mean CO.sub.2 expiratory pressure, PECO.sub.2, placing the expiratory CO.sub.2 sensor/probe inside a sealed bag placed in the expiratory outlet of the mechanical ventilator, and calculates the pulmonary physiological dead space, V.sub.D/V.sub.T, from the ratio between: the difference between the PaCO.sub.2 obtained by the device (b) and the PECO.sub.2 obtained by the device (d), and the PaCO.sub.2.

6. The system according to claim 1, wherein the transcutaneous capnography sensor of the device (c) is a transcutaneous oxycapnograph for the earlobe, which can be used in patients of any age.

7. The system according to claim 6, wherein the computer program (f5) of parameter estimates performs the following estimates: pHi, from the difference between the pHa obtained by the device (b) and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); pHgap, from the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); pHis, from the difference between the normal arterial pH and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b), the normal arterial pH being 7.4, % CO.sub.2gap, from the ratio between: the difference between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b), and the PgCO.sub.2, multiplied by 100; % CO.sub.2gap(tc), from the ratio between: the difference between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c), and the PgCO.sub.2, multiplied by 100; pHgap(tc), from the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); pHis(tc), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); pHgap(a-et), from the logarithm of the ratio between the PaCO.sub.2 measured with the device (b) and the EtCO.sub.2 obtained by the device (d); pHs(a-et), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PaCO.sub.2 measured by the device (b) and the EtCO.sub.2 obtained by the device (d); V.sub.D/V.sub.T(tc), from the ratio between: the difference between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d), and the PtcCO.sub.2; pHgap(tc-et), from the logarithm of the ratio between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d); and pHs(tc-et), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d).

8. The system according to claim 6, wherein the device (d) further measures the mean CO.sub.2 expiratory pressure, PECO.sub.2, placing the expiratory CO.sub.2 sensor/probe inside a sealed bag placed in the expiratory outlet of the mechanical ventilator, and calculates the pulmonary physiological dead space, V.sub.D/V.sub.T, from the ratio between: the difference between the PaCO.sub.2 obtained by the device (b) and the PECO.sub.2 obtained by the device (d), and the PaCO.sub.2.

9. The system according to claim 1, wherein the fifth specific module (f5) of parameter estimates performs the following estimates: pHi, from the difference between the pHa obtained by the device (b) and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); pHgap, from the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b); pHis, from the difference between the normal arterial pH and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b), the normal arterial pH being 7.4, % CO.sub.2gap, from the ratio between: the difference between the PgCO.sub.2 obtained by the device (a) and the PaCO.sub.2 obtained by the device (b), and the PgCO.sub.2, multiplied by 100; % CO.sub.2gap(tc), from the ratio between: the difference between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c), and the PgCO.sub.2, multiplied by 100; pHgap(tc), from the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); pHis(tc), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the PtcCO.sub.2 obtained by the device (c); pHgap(a-et), from the logarithm of the ratio between the PaCO.sub.2 measured with the device (b) and the EtCO.sub.2 obtained by the device (d); pHs(a-et), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PaCO.sub.2 measured by the device (b) and the EtCO.sub.2 obtained by the device (d); V.sub.D/V.sub.T(tc), from the ratio between: the difference between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d), and the PtcCO.sub.2; pHgap(tc-et), from the logarithm of the ratio between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d); and pHs(tc-et), from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PtcCO.sub.2 obtained by the device (c) and the EtCO.sub.2 obtained by the device (d).

10. The system according to claim 9, wherein the device (d) further measures the mean CO.sub.2 expiratory pressure, PECO.sub.2, placing the expiratory CO.sub.2 sensor/probe inside a sealed bag placed in the expiratory outlet of the mechanical ventilator, and calculates the pulmonary physiological dead space, V.sub.D/V.sub.T, from the ratio between: the difference between the PaCO.sub.2 obtained by the device (b) and the PECO.sub.2 obtained by the device (d), and the PaCO.sub.2.

11. The system according to claim 1, wherein the device (d) further measures mean CO.sub.2 expiratory pressure, PECO.sub.2, the expiratory CO.sub.2 sensor/probe configured to be placed inside a sealed bag placed in the expiratory outlet of the mechanical ventilator, and calculates the pulmonary physiological dead space, V.sub.D/V.sub.T, from the ratio between: the difference between the PaCO.sub.2 obtained by the device (b) and the PECO.sub.2 obtained by the device (d), and the PaCO.sub.2.

12. The system according to claim 1, wherein the connections (e) in the devices (a), (c) and (d) are made through the RS-232 serial ports, and the device (b) through its ethernet network connection.

13. The system according to claim 1, wherein the fifth specific module (f5) further estimates the following parameters related to the continuous measurement of the splanchnic tissue perfusion: gastric-expiratory CO.sub.2 gradient in percentage, % CO.sub.2gap(et), from the ratio between: the difference between the PgCO.sub.2 obtained by the device (a) and the EtCO.sub.2 obtained by the device (d), and the PgCO.sub.2, multiplied by 100; difference of expiratory-regional pH, pHgap(et), from the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the EtCO.sub.2 obtained by the device (d); and expiratory standard intramucosal pH, pHis(et), from the difference between the normal arterial pH and the logarithm of the ratio between the PgCO.sub.2 obtained by the device (a) and the EtCO.sub.2 obtained by the device (d), the normal arterial pH being 7.4.

14. The system according to claim 1, wherein the device (f) of reception, conversion, storage, integration, processing, management and display of the information is a personal computer.

15. A method for measuring, recording or monitoring the splanchnic tissue perfusion and the pulmonary physiological dead space in real time and in an automated way, either intermittently or continuously depending on the parameter to be measured, using the system defined in claim 1, wherein the method comprises the following steps: 1) measuring the PgCO.sub.2 by the device (a) of continuous or automated measuring, every 10 minutes, of the carbonic anhydride pressure in the lumen of the digestive tube; 2) measuring the pHa and the PaCO.sub.2 in a blood sample by the device (b) of intermittent measuring of the arterial pH and the CO.sub.2 arterial pressure; 3) measuring the PtcCO.sub.2 by the device (c) of continuous measuring of the CO.sub.2 transcutaneous pressure; 4) measuring the EtCO.sub.2, by the device (d) of continuous measuring of the end-expiratory CO.sub.2; 5) transferring the data of the measurements obtained from the measuring devices (a, b, c and d) to the device (f) of reception, conversion, storage, integration, processing, management and display of said data through the connections (e); 6) converting-normalizing the data transferred to the device (f) of reception, conversion, storage, integration, processing, management and display of the measurements by the conversion-normalization module (f2), 7) processing and integrating the data converted-normalized in the prior step by the processing and integration module (f3), 8) entering commands in the device (f) of reception, conversion, storage, integration, processing, management and display of said data, and estimating and viewing in an automated, continuous and real time way the parameters related to the measurement of the splanchnic tissue perfusion and the pulmonary physiological dead space, by the computer program (f5), the input interface (f6) and the output interface (f7).

16. The method according to claim 15, wherein the measurement of step 1) is performed in one of the organs selected from the group consisting of the stomach and the recto-sigmoidal colon.

17. The method according to claim 16, wherein when the measurement of step 1) is carried out in the stomach, the acid secretion of said organ is inhibited by the administration of one of the compounds selected from anti-H.sub.2 or proton pump inhibitors, to increase the reliability of the measurement.

18. The method according to claim 15, wherein in step 3) the device (c) is calibrated in vivo at the beginning of the measuring entering a PaCO.sub.2 value of a blood sample.

19. The method according to claim 15, wherein in step 4) the PECO.sub.2 is measured by the positioning of the expiratory CO.sub.2 sensor/probe in a large sealed bag connected to the expiratory outlet of the mechanical ventilator, wherein the expiratory gas is accumulated, and the Pressure of said gas in said bag is determine.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 depicts a scheme of the system for measuring, recording, and monitoring the splanchnic tissue perfusion and the pulmonary physiological dead space in an automated way, both continuously and intermittently, and in real time (pH-Tone instrument).

(2) FIG. 2 depicts a chart showing variation of the %CO.sub.2gap, pHis and pHgap at different levels of PaCO.sub.2 with a constant CO.sub.2gap of 10 mmHg.

(3) FIG. 3 depicts an illustrative scheme of a patient in intensive care, resuscitation, or operating room with a tonometry probe for the measurement of PgCO.sub.2 and a sensor for the earlobe for the measurement of PtcCO.sub.2, wherein the probe for the measurement of EtCO.sub.2 is found at the end of the endotracheal tube.

(4) FIG. 4 depicts a simulation of the output interface (f7) of the device (f) of reception, conversion, storage, integration, processing, management and display of the data recorded in the measurements, allowing the user to view in real time the information input in the device (f) and output from the computer module (f5), in both tabular and graphic form.

(5) FIG. 5 depicts a graph showing a 48 hours evolution of the standard pHi (pHis) in its three forms of calculation in a patient with ARDS: pHis Sample: calculated intermittently with the measurement of the PaCO.sub.2 obtained from a blood sample; pHis(tc): determined in a continuous and automated way with the measurement of the transcutaneous CO.sub.2 (present invention); and pHis(et): determined in a continuous and automated way with the measurement of the CO.sub.2 exhaled (present invention).

DESCRIPTION OF THE INVENTION

(6) The present invention relates to a new system for measuring, recording and monitoring the splanchnic tissue perfusion and the pulmonary physiological dead space in an automated way, both continuously and intermittently, and in real time, which is easy to manage and generates information easy to interpret.

(7) The system object of the present invention comprises at least (FIG. 1):

(8) a) a continuous measuring device of the carbonic anhydride pressure in the lumen of the digestive tube (PgCO.sub.2). This device includes a probe the positioning of which can be performed nasogastrically or recto-sigmoidally. The CO.sub.2 measurement can be performed by two types of probes: Probe with terminal silicone balloon permeable to CO.sub.2 that is filled with air: the measurement of the CO.sub.2 is performed in the apparatus (capnograph) by the extraction, analysis and reintroduction of the gas sample in the balloon, in an intermittent (every 10 minutes) and automated way, as the General Electric M-Tone Module, or another one that might be marketed. Probe with a fibre optic sensor in its patient end: “continuous measuring in situ”, as the developed by The Institute of Chemical Process Development and Control, or other that might be marketed.

(9) b) a standard intermittent measuring device of the arterial pH (pHa) and CO.sub.2 arterial pressure (PaCO.sub.2) of a blood sample;

(10) c) a continuous measuring device of the CO.sub.2 transcutaneous pressure (PtcCO.sub.2) consisting of a transcutaneous capnography sensor; and

(11) d) a continuous measuring device of the end-expiratory CO.sub.2 (EtCO.sub.2) consisting of an expiratory air standard capnograph, the probe or sensor of which is connected to the patient's airway;

(12) e) specific connections between the enumerated measuring devices (a, b, c and d) and an f) device. These connections are preferably made in the devices a, c and d through the RS-232 serial ports thereof, and in device b, through its network connection (Ethernet), since its location is usually remote.

(13) f) a device of reception, conversion, storage, integration, processing, management and display of data recorded in the continuous, automated and real-time measurements.

(14) The device (f) of reception, conversion, storage, integration, processing, management and display of data recorded in the measurements comprises at least the following elements: a computer program module (f1) of reception and storage of the measurements performed with the measuring devices (a, b, c and d), a second specific module (f2) of conversion-normalization of the data received and stored in the module (f1) of reception and storage, a third module (f3) of processing and integration of the data normalized by the normalization module (f2), a fourth program module (f4) of storage of the data processed by the processing module (f3); a fifth specific module (f5) of automated, continuous and real time estimate of the parameters related to the measurement of the splanchnic tissue perfusion and the pulmonary physiological dead space, from the data derived from the 4.sup.th storage module (f4) that have been previously processed by the processing module (f3); an input interface (f6) allowing the user to enter commands in the computer program (f5) of parameter estimate, as well as additional data; an output interface (f7) allowing the user to view in real time the information input in the device (f) and the output from the computer module (f5), in both tabular and graphic form; an eighth module (f8) for recording the parameters estimated by the module (f5), for the subsequent recovery and analysis thereof; and an alarm (f9) for checking the operation of the device (f) and the specific connections (e), to detect problems in operating and receiving measurements, and parameters programmable alarm (measurement values exceeded) by the module (f5), independent of that existing in the measuring equipment.

(15) The parameters related to the measurement of the splanchnic tissue perfusion and the pulmonary physiological dead space calculated by the estimate computer program (f5) are the following: CO.sub.2 arterial pressure (PaCO.sub.2), which is measured intermittently by the device (b) or is estimated continuously as a function of the PtcCO.sub.2; difference of systemic-regional pH (pHgap), which is estimated as a function of the PgCO.sub.2 and the measured PaCO.sub.2; intramucosal pH in the digestive tube (pHi), which is estimated as a function of the pHa, the PgCO.sub.2 and the measured PaCO.sub.2, standard intramucosal pH (pHis) which is estimated as a function of the normal arterial pH, the PgCO.sub.2 and the measured PaCO.sub.2, the normal arterial pH being 7.4. gradient between the pressures of gastric CO.sub.2 and arterial CO.sub.2 in % (% CO.sub.2gap), which is estimated as a function of the PgCO.sub.2 and the measured PaCO.sub.2; gradient between the pressures of gastric CO.sub.2 and transcutaneous CO.sub.2 in % (% CO.sub.2gap(tc)), which is estimated as a function of the PgCO.sub.2 and the PtcCO.sub.2; difference of transcutaneous-regional pH (pHgap(tc)), which is estimated as a function of the PgCO.sub.2 and the PtcCO.sub.2; transcutaneous standard intramucosal pH (pHis(tc)), which is estimated as a function of the normal arterial pH, the PgCO.sub.2 and the PtcCO.sub.2; difference of the arterial-respiratory pH (pHgap(a-et)), which is estimated as a function of the measured PaCO.sub.2 and the EtCO.sub.2; arterial-respiratory standard pH (pHs(a-et)), which is estimated as a function of the normal arterial pH, the measured PaCO.sub.2 and the EtCO.sub.2; pulmonary physiological dead space, V.sub.D/V.sub.T, which is estimated as a function of the PaCO.sub.2 obtained by the device (b) and the PECO.sub.2 obtained by the device (d); transcutaneous pulmonary physiological dead space (V.sub.D/V.sub.T(tc)), which is estimated as a function of the PtcCO.sub.2 and the EtCO.sub.2; difference of transcutaneous-expiratory pH (pHgap(tc-et)), which is estimated as a function of the PtcCO.sub.2 and the EtCO.sub.2; and transcutaneous-expiratory standard pH (pHs(tc-et)), which is estimated as a function of the normal arterial pH, the PtcCO.sub.2 and the EtCO.sub.2.

(16) Preferably, the measuring device (a) of the carbonic anhydride pressure in the lumen of the digestive tube is the M-Tone Module of the Datex company, which allows the obtainment of the measurement in an automated way every 10 minutes. In a particular embodiment, the device (a) would be constituted by a Datex Ohmeda S5 multiparametric system with an M-Tone tonometry module and tonometry probe output. The information depicting media in this system show the values of PGCO.sub.2, EtCO.sub.2 and the difference between them P(g-Et)CO.sub.2, rounding off decimals, as well as the scale of time between PgCO.sub.2 measurements. However, it only provides the numerical value of the latestmeasurement, neither does it represent the data graphically nor does it show trends facilitating the interpretation thereof and assessing its evolution over time.

(17) Preferably, the pHa and PaCO.sub.2 values measured by the device (b) of the intermittent blood samples are entered after the analysis either manually through the keyboard or received in an automated way through the Ethernet connection.

(18) The selection of the CO.sub.2 transcutaneous pressure measurement (PtcCO.sub.2) is due to the fact that it can be performed continuously and bloodless, and it is the one that approximates the closest to the real value of the CO.sub.2 arterial Pressure (PaCO.sub.2). The measurement of this parameter has not been used previously for the purpose of assessing splanchnic tissue perfusion. Preferably, the transcutaneous capnography sensor of the device (c) is a transcutaneous oxycapnograph for the earlobe. In a particular embodiment, the transcutaneous oxycapnograph for the earlobe is the “Tosca” model of the Radiomether company, comprising 2 sensors, a pulsoxymeter not used in the present invention, and a transcutaneous capnograph (sensor employed in the present invention), since it can be used in patients of any age. Although other manufacturers, such as Sentec, have similar equipment. The Radiomether Tina model can also be used, or any other one.

(19) On its side, the CO.sub.2 end-expiratory measurement (EtCO.sub.2) has the main purpose of estimating, both intermittently (with the PaCO.sub.2 measurement) and continuously (with the PtcCO.sub.2 measurement), the pulmonary physiological dead space. The continuous estimate has not been described so far in the literature. This measurement can be obtained with any expiratory air capnograph; there are many manufacturers of this device. Preferably, if the patient is intubated, the EtCO.sub.2 measuring probe is attached to the end of the endotracheal tube.

(20) Preferably, the parameter estimate computer program (f5), the device (f) of reception, conversion, storage, integration, processing, management and display of the data recorded in the measurements, performs the following calculations: Intermittent calculation of parameters for assessment of the splanchnic perfusion: the measurements obtained by the devices (a) and (b) are employed. These calculations have been the ones classically used. However, our invention, unlike other systems, does not employ the usual equations mentioned in the State of the Art section, but simplified equations, in addition to providing a new parameter, the CO.sub.2gap in percentage (% CO.sub.2gap): Gastric or sigmoidal intramucosal pH (pHi), from the difference between the pHa and the logarithm of the ratio between the PgCO.sub.2 and the PaCO.sub.2 measured, expressed by the formula
pHi=pHa−log PgCO.sub.2/PaCO.sub.2; Difference of gastric-arterial or systemic-regional pH (pHgap), from the logarithm of the ratio between the PgCO.sub.2 and the measured PaCO.sub.2, expressed by the formula
pHgap=log PgCO.sub.2/PaCO.sub.2; Standard intramucosal pH (pHis), from the difference between the normal arterial pH and the logarithm of the ratio between the PgCO.sub.2 and the PaCO.sub.2 measured, the normal arterial pH being 7.4, expressed by the formula
pHis=7.4−log PgCO.sub.2/PaCO.sub.2; Gradient of gastric-arterial or systemic-regional CO.sub.2 in percentage (% CO.sub.2gap), from the ratio between: the difference between the PgCO.sub.2 and the PaCO.sub.2 measured, and the PgCO.sub.2, multiplied by 100, expressed by the formula
% CO.sub.2gap=(PgCO.sub.2−PaCO.sub.2)*100/PgCO.sub.2.

(21) By requiring a blood sample to obtain the arterial pH (pHa) and the CO.sub.2 arterial pressure (PaCO.sub.2), these parameters can not be calculated continuously, but our invention offers in real time an update of these parameters with the changes in the gastric measurement (PgCO.sub.2), using the values of the latest blood sample. The entering of the pH and PaCO.sub.2 blood values can be performed manually (without communication) or automatedly. This latter form has the advantage of saving time, and also improves the accuracy when performing data entry in real time, avoiding oversights or delays in the entry thereof.

(22) As it can be seen, with these simplified equations all the regional parameters are calculated using parameters measured directly and not previously calculated (as bicarbonate or pHi). Moreover, the use of constants, which may vary with temperature changes or another one, is eliminated.

(23) Although the CO.sub.2 gradient (CO.sub.2gap) has been appreciated as the key parameter in the monitoring of the splanchnic perfusion by some authors (17, 18), it has in our opinion a serious disadvantage that has provably caused the tonometric technique to fall into disuse: the interpretation of its values depends on the level of arterial PCO.sub.2. Thus, it is not possible to establish a range of normality for this parameter, since this range will vary with the changes in the PaCO.sub.2. For this reason, in the present system said parameter has been substituted by the % CO.sub.2gap, which like the pHgap and the pHis, takes into account the level of the PaCO.sub.2 (FIG. 2). Calculations for continuous monitoring of the splanchnic perfusion: the measurements obtained by the devices (a) and (c) are used: CO.sub.2 gastric-transcutaneous or transcutaneous-regional gradient in percentage, from the ratio between: the difference between the PgCO.sub.2 and the PtcCO.sub.2, and the PgCO.sub.2,

(24) multiplied by 100, expressed by the formula
% CO.sub.2gap(tc)=(PgCO.sub.2−PtcCO.sub.2)*100/PgCO.sub.2; Difference of gastric-transcutaneous or transcutaneous-regional pH, from the logarithm of the ratio between the PgCO.sub.2 and the PtcCO.sub.2, expressed by the formula
pHgap(tc)=log PgCO.sub.2/PtcCO.sub.2; and Transcutaneous standard intramucosal pH, from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PgCO.sub.2 and the PtcCO.sub.2, expressed by the formula
pHis(tc)=7.4−log PgCO.sub.2/PtcCO.sub.2.

(25) The introduction of the normal pH constant allows the obtainment of values in the pH scale easy to interpret. Intermittent calculation of the pulmonary physiological dead space: the measurements obtained by the devices (b) and (d) are used: Difference of arterial-expiratory pH, from the logarithm of the ratio between the PaCO.sub.2 and the EtCO.sub.2, expressed by the formula
pHgap(a-et)=log PaCO.sub.2/EtCO.sub.2; and Arterial-expiratory standard pH, from the difference between the normal arterial pH and the logarithm of the ratio between the measured PaCO.sub.2 and the EtCO.sub.2, expressed by the formula
pHs(a-et)=7.4−log PaCO.sub.2/EtCO.sub.2.

(26) It should be noted that our system also makes it possible to perform the exact calculation of the pulmonary physiological dead space (V.sub.D/V.sub.T), expressed by the formula (PaCO.sub.2−PECO.sub.2)/PaCO.sub.2. For this purpose, the use of the mean expiratory CO.sub.2 (PECO.sub.2) instead of the EtCO.sub.2 is required. For measurement thereof, the exhaled CO.sub.2 sensor/probe (device d) must be removed from the patient's airway and introduced in a sealed manner in a large bag that receives all the expiratory air from the patient. These measurements are usually performed in the critically ill patient, who is usually intubated, so the expiratory gas collection is simple (the bag is connected to the expiratory gas outlet of the mechanical ventilator). However, it can only be performed when intermittent flow mechanical ventilators (MV) and in controlled mode (CMV) are used, since in SIMV modes, the constant basic flow of the MV will contaminate the sample in the bag. Neither is its measurement possible in the neonatal field due to the systematic use of continuous flow MV at these ages. On the other hand, it is difficult to achieve the sealing of the bag, which can cause inaccurate measurements due to the high diffusivity of CO.sub.2. This is the reason why the present invention suggests the parameters pHgap(a-et) and pHs(a-et), that have not been described so far, since they use EtCO.sub.2, avoiding the disadvantages of the measurement of the PECO.sub.2. These calculations, even though they do not exactly measure the V.sub.D/V.sub.T, can be useful to assess the variations thereof in the critically ill patient. Probably, these variations can also be assessed if we substitute the PECO.sub.2 by the EtCO.sub.2 in the calculation equation of the V.sub.D/V.sub.T. This variant of calculation of the V.sub.D/V.sub.T is the one our system usually provides, when the CO.sub.2 sensor/probe (device d) is positioned in the patient's airway. Calculations for the continuous assessment of the pulmonary physiological dead space: the measurements obtained by the devices (c) and (d) are used: Transcutaneous pulmonary physiological dead space, from the ratio between: the difference between the PtcCO.sub.2 and the EtCO.sub.2, and the PtcCO.sub.2, expressed by the formula
V.sub.D/V.sub.T(tc)=(PtcCO.sub.2−EtCO.sub.2)/PtcCO.sub.2; Difference of transcutaneous-expiratory pH, from the logarithm of the ratio between the PtcCO.sub.2 and the EtCO.sub.2, expressed by the formula
pHgap(tc-et)=log PtcCO.sub.2/EtCO.sub.2; and Transcutaneous-expiratory standard pH, from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PtcCO.sub.2 and the EtCO.sub.2, expressed by the formula
pHs(tc-et)=7.4−log PtcCO.sub.2/EtCO.sub.2.

(27) For the continuous assessment of the VD/VT (VD/VT(tc)), the use of EtCO.sub.2 instead of the PECO.sub.2 is proposed herein. For the reasons set forth above, we sacrifice accuracy for convenience. While not providing exact values, we believe that it will allow proper assessment of the changes in this parameter. However, to obtain accurate measurements it is enough to change the position of the CO.sub.2 sensor, as we have already discussed.

(28) In another preferred embodiment, the computer program (f5) also estimates also the following parameters related to the continuous measurement of the splanchnic tissue perfusion, from the measurements obtained by the devices (a) and (d): Gastric-expiratory or expiratory-regional CO.sub.2 gradient in percentage, from the ratio between: the difference between the PgCO.sub.2 and the EtCO.sub.2, and the PgCO.sub.2,

(29) multiplied by 100, expressed by the formula
% CO.sub.2gap(et)=(PgCO.sub.2−EtCO.sub.2)*100/PgCO.sub.2; Difference of gastric-expiratory or expiratory-regional pH, from the logarithm of the ratio between the PgCO.sub.2 and the EtCO.sub.2, expressed by the formula
pHgap(et)=log PgCO.sub.2/EtCO.sub.2; and expiratory standard intramucosal pH, from the difference between the normal arterial pH (7.4) and the logarithm of the ratio between the PgCO.sub.2 and the EtCO.sub.2, expressed by the formula
pHis(et)=7.4−log PgCO.sub.2/EtCO.sub.2.

(30) The parameters described have the advantage, over the classical parameters, of not requiring the extraction and analysis of blood samples for the calculation thereof and, with it, they can be obtained in an automated and continuous way.

(31) Preferably, the device (f) of reception, conversion, storage, integration, processing, management and display of the information is a personal computer.

(32) The present invention relates also to the use of the device described for measuring, recording and monitoring the splanchnic tissue perfusion and the pulmonary physiological dead space in a continuous, real time and automated way. Said measurement, said recording and said monitoring comprise at least the following steps: 1) measuring the PgCO.sub.2 by the device (a) of continuous measuring of the carbonic anhydride pressure in the lumen of the digestive tube; 2) measuring the pHa and the PaCO.sub.2 on a blood sample by the device (b) of intermittent measuring of the arterial pH and the CO.sub.2 arterial pressure; 3) measuring the PtcCO.sub.2 by the device (c) of continuous measuring of the CO.sub.2 transcutaneous pressure; 4) measuring the EtCO.sub.2, by the device (d) of continuous measuring of the end-expiratory CO.sub.2; 5) transferring the data of the measurements obtained from the measuring devices (a, b, c and d) to the device (f) of reception, conversion, storage, integration, processing, management and display of said data through the connections (e); 6) converting the data transferred to the device (f) of reception, conversion, storage, integration, processing, management and display of the measurements by the conversion-normalization module (f2), 7) processing and integrating the data converted-normalized in the prior step by the module (f3) of processing and integration of the data, 8) entering commands in the device (f) of reception, conversion, storage, integration, processing, management and display of said data, and estimating and viewing in an automated, continuous and real time way the parameters related to the measurement of the splanchnic tissue perfusion and the pulmonary physiological dead space, by the computer program (f5), the input interface (f6) and the output interface (f7).

(33) Preferably, the measurement of step 1) is performed either in the stomach or in the sigmoidal colon, using the probe with optic fibre sensor or with an already described terminal silicone balloon.

(34) Also preferably, when the measurement of step 1) is carried out in the stomach, the acid secretion of said organ must be inhibited by administering one of the compounds selected from anti-H.sub.2 and proton pump inhibitors, to increase the reliability of the measurement.

(35) In a preferred embodiment, in step 3) the device (c) is calibrated “in vivo” at the beginning of the measuring entering a PaCO.sub.2 value of a blood sample.

(36) In another preferred embodiment, the PECO.sub.2 is measured in step 4) by a large bag wherein the expiratory gas is accumulated and the CO.sub.2 Pressure of said gas is determined in said bag by the CO.sub.2 probe/sensor of the device d, which is located in the bag in a sealed way.

(37) The scope of application of the monitoring system proposed is exclusively the hospital:

(38) 1) Critically ill patients admitted to ICU and resuscitation units: the pHi has shown to be a sensitive but little specific prognostic indicator in the critically ill patient, having shown its usefulness as a multiple organ failure and death predictor in multiple situations, both in the adult and the pediatric patient. Thus, its prognostic usefulness has shown itself to be superior to that of the hemodynamic and systemic oxygenation variables. Its use in interventionist studies to guide the therapy is, however, controversial. Thus, while Gutierrez et al (19) and Ivatury et al (20) observed how the therapy guided by the pHi improved the prognosis of the patients, Gomersall et al (21), did not find any benefit in the group whose therapy was guided by means of the pHi. The limitations of the technique described could explain this deficit. The improvements achieved with the present invention provide the tool necessary to direct the therapy in these patients.

(39) 2) The patient undergoing cardiovascular surgery or major surgery, thoracic and abdominal, including liver, intestinal (detection of celiac and mesenteric ischemia) and lung transplant: various studies suggest that the sigmoidal tonometry can be useful to predict the occurrence of ischemic cholitis secondary to tissue hypoxia, main cause of morbidity and mortality after major abdominal vascular surgery. Likewise, the hypoperfusion of the colon detected by tonometry, can be associated to endotoxemia and release of cytokines, which may condition the evolution to MOF and death.

(40) 3) Diagnostic assay of celiac and mesenteric symptomatic vascular disease that allows the prediction of the usefulness of surgery.

(41) 4) Assessment of the alterations in the ventilation-perfusion in the critically ill patient. These alterations are very frequent in this type of patients, particularly when the pulmonary blood flow decreases (e.g., situations of shock, pulmonary embolism, cardiopulmonary resuscitation), when the alveoli are overdistended by positive pressure ventilation and when the alveolo-capillary interface is destroyed (e.g., emphysema).

(42) The invention described herein presents the following advantages over other systems known in the field of the art:

(43) 1. Uses for obtaining the measurements clinical equipment commercially available from different manufacturers. Therefore, the dependence on a single manufacturer is avoided. Moreover, the user will be able to simplify the acquisition of the present system if he uses the measuring equipment available at his Centre. It will also be possible to continue using this equipment independently of the present invention. At the same time, the system will allow all the technological improvements that may be marketed for making measurements of parameters to be incorporated. In this sense, if devices such as Paratrend or other similar ones for continuous measuring of the pHa and the PaCO.sub.2 were marketed again, the now intermittent calculations will be able to be carried out continuously.

(44) 2. Intermittent monitoring of the splanchnic perfusion: In addition to pHi, it provides the calculation of other classical parameters such as pHgap and pHis. These two parameters, although described in the literature, have not been provided by any marketed equipment. For the calculation of all the regional parameters their simplified equations are used, only using the parameters measured directly. In this way, interference from previous calculations and changes in the constants of the standard formulae are eliminated. Substitutes the calculation of the CO.sub.2gap, having serious disadvantages, by a new parameter, % CO.sub.2gap, overcoming these limitations. For these intermittent calculations, the introduction of measurements derived from blood samples is required. These data can be entered manually (like in other marketed devices) or automatically through the connection with the communications port of the pH and gas analyzer. This latter form has the advantage of saving time for the health care provider, and also improving the accuracy by performing the data entry in real time, avoiding oversights or delays in the entry. Although the parameters requiring a blood sample can only be determined intermittently, the present invention offers, in real time, an update of these parameters with the changes of the gastric measurement (PgCO.sub.2), using the values of the latest blood sample.

(45) 3. Continuous monitoring of the splanchnic perfusion: Through the measurements of PgCO.sub.2 and PtcCO.sub.2 obtained from marketed equipment, the present equipment performs the automated and continuous calculation of new regional parameters, not described so far, of easy clinical interpretation, with ranges of normality fixed and independent of the CO.sub.2 blood values. The PtcCO.sub.2 had not been used previously for this purpose. Provides other regional parameters of continuous measuring not described until now through the integration of the measurements of PgCO.sub.2 and EtCO.sub.2. Improves the health care activity by displaying the information continuously and in real time. Decreases the consumption of time by the health care provider and improves the accuracy of the information stored, by carrying out all the functions automatedly.

(46) 4. Intermittent and continuous monitoring of the pulmonary physiological dead space: It integrates the measurement of the CO.sub.2 exhaled with the PaCO.sub.2 for intermittent monitoring, and with the PtcCO.sub.2 for continuous monitoring, of the alterations in the pulmonary physiological dead space by calculating the V.sub.D/V.sub.T and the other derived parameters not described so far. This type of monitoring, that allows assessment of alterations in the pulmonary ventilation/perfusion ratio, is currently not provided by any marketed equipment.

(47) 5. The information is displayed in tabular and graphic form, easy to be interpreted by clinicians. It assesses the evolution over time by depicting a trends graph.

(48) 6. It is provided with an operating alarm system (problem with the reception of the measurements as disconnections, etc.) and a programmable clinical alarm (measurement values exceeded).

(49) 7. It saves the information in databases, so that the same can be subsequently recovered.

(50) Therefore, the invention herein described integrates measurements performed by clinical equipment that has not been used previously for this purpose (as the transcutaneous capnograph), to provide in a continuous and automated way new parameters useful for the estimate of the splanchnic perfusion-oxygenation and the pulmonary physiological dead space that are currently not provided by any other marketed system.

ABBREVIATIONS OF THE FIELD OF THE ART

(51) ATP, adenosine triphosphate CO.sub.2gap or P(g-a)CO.sub.2, gastric-arterial or systemic-regional CO.sub.2 gradient (=PgCO.sub.2−PaCO.sub.2) CO.sub.2gap(et) or P(g-Et)CO.sub.2, gastric-expiratory or expiratory-regional CO.sub.2 gradient (=PgCO.sub.2−EtCO.sub.2) % CO.sub.2gap, gastric-arterial or systemic-regional CO.sub.2 gradient in percentage (=(PgCO.sub.2−PaCO.sub.2)*100/PgCO.sub.2) % CO.sub.2gap(et), gastric-expiratory or expiratory-regional CO.sub.2 gradient in percentage (=(PgCO.sub.2−PetCO.sub.2)*100/PgCO.sub.2) % CO.sub.2gap(tc), gastric-transcutaneous or transcutaneous-regional CO.sub.2 gradient in percentage (=(PgCO.sub.2−PtcCO.sub.2)*100/PgCO.sub.2) EtCO.sub.2, end-expiratory carbonic anhydride pressure [HCO.sub.3.sup.−], bicarbonate concentration PaCO.sub.2, arterial carbonic anhydride pressure PECO.sub.2, mean expiratory carbonic anhydride pressure PgCO.sub.2, carbonic anhydride pressure in the lumen of the digestive tube (usually in the stomach, but also in the sigmoidal colon) pHa, arterial pH pHgap, difference of gastric-arterial or systemic-regional pH (=pHa−pHi; it can also be calculated by the simplified equation=log PgCO.sub.2/PaCO.sub.2) pHgap(a-et), difference of the arterial-expiratory pH (=log PaCO.sub.2/EtCO.sub.2) pHgap(et), difference of the gastric-expiratory or expiratory-regional pH (=log PgCO.sub.2/EtCO.sub.2) pHgap(tc), difference of gastric-transcutaneous or transcutaneous-regional pH (=log PgCO.sub.2/PtcCO.sub.2) pHgap(tc-et), difference of transcutaneous-expiratory pH (=log PtcCO.sub.2/EtCO.sub.2) pHi, intramucosal pH in the digestive tube (usually gastric, but also in the sigmoidal colon) (=6.1+log 10([HCO3.sup.−PgCO.sub.2*0.03); it can also be calculated by the simplified equation=pHa−log PgCO.sub.2/PaCO.sub.2) pHis, standard intramucosal pH (=7.4−pHgap; it can also be calculated by the simplified equation=7.4−log PgCO.sub.2/PaCO.sub.2) pHis(et), expiratory standard intramucosal pH (=7.4−log PgCO.sub.2/EtCO.sub.2) pHis(tc), transcutaneous standard intramucosal pH (=7.4−log PgCO.sub.2/PtcCO.sub.2) pHs(a-et), arterial-expiratory standard pH (=7.4−log PaCO.sub.2/EtCO.sub.2) pHs(tc-et), transcutaneous-expiratory standard pH (=7.4−log PtcCO.sub.2/EtCO.sub.2) PaO.sub.2, oxygen arterial pressure PtcCO.sub.2, CO.sub.2 transcutaneous pressure ARDS, acute respiratory distress syndrome PSS, physiological saline serum V.sub.D/V.sub.T, pulmonary physiological dead space (=(PaCO.sub.2−PECO.sub.2)/PaCO.sub.2) V.sub.D/V.sub.T(tc), transcutaneous pulmonary physiological dead space (=(PtcCO.sub.2−EtCO.sub.2)/PtcCO.sub.2)

BIBLIOGRAPHY

(52) 1. Fiddian-Green R G. Gastric intramucosal pH, tissue oxygenation and acid-base balance. Br. J. Anaesth. 1995; 74: 591-606 2. Fiddian-Green R G. Tonometry: theory and applications. Intensive Care World 1992; 9: 60-65 3. Pinsky M R, Schlichtig R. Regional oxygen delivery in oxygen supply-dependent states. Intensive Care Med. 1990; 16: S169-171 4. Hartmann M, Montgomery A, Jonsson K, et al. Tissue oxygenation in hemorrhagic shock measured as transcutaneous oxygen tension, subcutaneous oxygen tension, and gastrointestinal intramucosal pH in pigs. Crit. Care Med 1991; 19: 205-210 5. Schlichting E, Lyberg T. Monitoring of tissue oxygenation in shock: an experimental study in pigs. Crit. Care Med 1995; 23: 1703-1710 6. Antonson J B, Boyle C C, Kurithoff K L, et al. Validation of tonometric measurement of intramural pH during endotoxemia and mesenteric occlusion in pigs. Am J Physiol 1990; 259: G519-523 7. Boda D, Muranyi L. “Gastrotonometry”. An aid to the control of ventilation during artificial respiration. Lancet 1959; 273: 181-182 8. Bergofsky E H. Determination of tissue O.sub.2 tensions by hollow visceral tonometers: effect of breathing enriched O.sub.2 mixtures. J Crit. Invest 1964; 43: 193-200 9. Dawson A M. Small bowel tonometry: assessment of small gut mucosal oxygen tension in dog and man. Nature 1965; 206: 943-944 10. Fiddian-Green R G, Pittenger G, Whitehouse W M. Back-diffusion of CO.sub.2 and its influence on the intramural pH in gastric mucosa. J Surg Res 1982; 33: 39-48 11. Clark C H, Gutierrez G. Gastric intramucosal pH: a noninvasive method for the indirect measurement of tissue oxygenation. Am J Critical Care 1992; 2: 53-60 12. Kolkman J J, Otte J A, Groeneveld B J. Gastrointestinal luminal PCO.sub.2 tonometry: an update on physiology, methodology and clinical applications. Br J Anaesth 2000; 84: 74-86 13. Calvo C, Ruza F, López-Herce J, et al. Usefulness of gastric intramucosal pH for monitoring hemodynamic complications in critically ill children. Intensive Care Med 1997 23: 1268-1274 14. Noone R B, Mythen M G, Vaslef S N. In vitro validation of an automated on-line gastrointestinal tonometer (the Tonocap). Crit. Care Med 1997; 25(1S): A137 15. Barry B, Mallick A, Hartley G, et al. Comparison of air tonometry with gastric tonometry using saline and other equilibrating fluids: an in vivo and in vitro study. Intensive Care Med 1998; 24: 777-784 16. Janssens U, Graf J, Koch K C, et al. Gastric tonometry: in vivo comparison of saline and air tonometry in patients with cardiogenic shock. Br J Anaesth 1998; 81: 676-680 17. Schlichtig R, Mehta N, Gayowki T J P, et al. Tissue-arterial PCO2 difference is a better marker of ischemia than intramural pH(pHi) or arterial pH-pHi difference. J Crit. Care 1996; 11: 51-56 18. Vincent J L. Gastric mucosal pH is definitely obsolete. Please tell us more about gastric mucosal PCO2. Crit. Care Med 1998; 26: 1479-1480 19. Gutierrez G, Palizas F, Doglio G, et al. Gastric intramucosal pH as a therapeutic index of tissue oxygenation in critically ill patients. Lancet 1992; 339: 195-199 20. Ivatury R R, Simon R J, Islam S, et al. A prospective randomized study of end points of resuscitation after major trauma: global oxygen transport indices versus organ-specific gastric mucosal pH. J Am Coll Surg 1996; 183: 145-154 21. Gomersall C D, Joint G M, Freebairn R C, et al. Resuscitation of critically ill patients based on the results of gastric tonometry: a prospective, randomized, controlled trial. Crit. Care Med 2000; 28: 607-614

FIGURES

(53) FIG. 1. Scheme of the system for measuring, recording and monitoring the splanchnic tissue perfusion and the pulmonary physiological dead space in an automated way, both continuously and intermittently, and in real time (pH-Tone instrument).

(54) 1. Critically ill patient in: intensive care, resuscitation or operating room.

(55) 2. Clinical equipment (a) for the measurement of the PgCO.sub.2: 2.1. General Electric M-Tone Module 2.2. Instrument of the Institute of Chemical Process Development and Control 2.3. Other

(56) 3. Standard blood pH and gas analyzer (b): intermittent measurement of pHa and PaCO.sub.2 (multiple manufacturers).

(57) 4. Clinical equipment (c) for the measurement of the PtcCO.sub.2: Radiomether “Tosca” oxycapnograph, Sentect oxycapnograph or other transcutaneous capnographs.

(58) 5. Clinical equipment (d) for the measurement of the EtCO.sub.2 and the PECO.sub.2 (multiple manufacturers).

(59) 6. Device (f) of reception, conversion, storage, integration, processing, management and display of the data recorded in the measurements.

(60) Calculation of Derived Parameters:
measuring device (a)+measuring device (b)=Intermittent monitoring of the splanchnic perfusion.
measuring device (a)+measuring device (c)=Continuous monitoring of the splanchnic perfusion.
measuring device (b)+measuring device (d)=Intermittent monitoring of the pulmonary physiological dead space.
measuring device (c)+measuring device (d)=Continuous monitoring of the pulmonary physiological dead space.

(61) FIG. 2. Variation of the % CO.sub.2gap, pHis and pHgap at different levels of PaCO.sub.2 with a constant CO.sub.2gap of 10 mmHg. As it can be seen, a CO.sub.2gap of 10 mmHg is pathological when the arterial CO.sub.2 level is normal or low, but not when this is high. Therefore, the interpretation of its values depends on the level of the arterial PCO.sub.2 and it is not possible to establish a normal range for this parameter, since it varies with the values of the PaCO.sub.2. It is also not possible to compare series of patients since the meaning of a certain value of CO.sub.2gap is to be varied as a function of the level of PaCO.sub.2 that each patient had. In the inventors' opinion, and contrary to the opinion of other authors (17, 18), this fact seriously limits the usefulness of this parameter, where the % CO.sub.2gap, the pHis or the pHgap should be preferably used.

(62) FIG. 3. Illustrative scheme of a patient in intensive care, resuscitation or operating room with a tonometry probe for the measurement of PgCO.sub.2 and a sensor for the earlobe for the measurement of PtcCO.sub.2. The probe for the measurement of EtCO.sub.2 is found at the end of the endotracheal tube.

(63) 1. Intubated patient.

(64) 2. Sonometric probe for the measurement of PgCO.sub.2.

(65) 4. Sensor for the earlobe for the measurement of PtcCO.sub.2.

(66) 5. EtCO.sub.2 measuring probe.

(67) 7. Endotracheal tube (intubation).

(68) FIG. 4. Simulation of the output interface (f7) of the device (f) of reception, conversion, storage, integration, processing, management and display of the data recorded in the measurements, allowing the user to view in real time the information input in the device (f) and output from the computer module (f5), in both tabular and graphic form. Observe the graphs of continuous monitoring of the pHis and CO.sub.2gap, in its two forms of calculation (tc) and (et).

(69) FIG. 5. 48 hours evolution of the standard pHi (pHis) in its three forms of calculation in a patient with ARDS: pHis Sample: calculated intermittently with the measurement of the PaCO.sub.2 obtained from a blood sample. pHis(tc): determined in a continuous and automated way with the measurement of the transcutaneous CO.sub.2 (present invention). pHis(et): determined in a continuous and automated way with the measurement of the CO.sub.2 exhaled (present invention).

(70) Observe the perfect correlation between the pHis calculated with blood sample and transcutaneous sample, and the important differences of both with the pHis(et). These differences can be attributed to variations in the pulmonary ventilation and perfusion. For these measurements, no previous calibration of the PtcCO.sub.2 was performed with a measurement of the PaCO.sub.2. With this calibration, the correlation between the pHis and the pHis(tc) is still further improved.