Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise
NCT ID: NCT03718780
Last Updated: 2022-06-14
Study Results
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Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2019-02-22
2024-02-22
Brief Summary
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The evaluation will be done in 2 different settings:
* intensive care patients, equipped, for their routine clinical care, with an arterial line; this allows for a precise timed comparison between PaCO2 and PtCO2 readouts;
* routine exercise test, where blood gas evaluation is done essentially by means of arterialized earlobe capillary sampling.
Following assessment of validity of the measurement (and the lag time PaCO2-PtCO2 which might be necessary to introduce as a correction), evolution of dead space during excise test will be tested in different conditions: Healthy subjects, patients with Chronic Obstructive Pulmonary Disease (COPD), chronic heart failure (CHF), hyperventilation, Pulmonary artery hypertension (PAH), or interstitial lung disease (ILD)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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A1: Patient in intensive care
Patient in intensive care (n=10):
in patients in the intensive care unit of the Centre Hospitalier Metropole Savoie (Chambéry, France), where repeated arterial blood gas analysis is routinely performed (Patients equipped for their usual care with an arterial catheter, enabling repeated arterial blood gas determination ).
PaCO2 and Pt CO2 will be measured simultaneously at rest, and during conditions inducing PaCO2 modifications (ventilator settings modifications, or exercise as per routine rehabilitation) Comparison will be done between arterial PaCO2 and PtCO2
simultaneous determination of PaCO2 and PtCO2
Patients in intensive care, equipped, for their routine clinical management, with an arterial catheter blood line, will have a simultaneous determination of PaCO2 and PtCO2:
* 1\) at rest; 2 arterial CO2/PtCO2 determinations will be carried out, 10 minutes apart
* 2\) During the muscular exercise part of their routine rehabilitation program (whatever it might be, limbs active mobilization, walking, etc...) : several arterial /PtCO2 samples will be collected during the first minutes of their muscular routine: 30 sec, 1 minute, 1 ½ minute, 2, 2 ½ , 3, 4, 5 minutes, 10 minutes (end of exercise). This will generate several couples of blood/transcutaneous CO2 determinations
A2: Healthy subjects
Healthy subjects performing a voluntary hyperventilation, in the laboratory room where routine exercise testing is usually done.
Comparison will be done between arterialized PaCO2 and PtCO2, at rest, and during an induced voluntary hyperventilation.
Hyperventilation test
Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest (0), then 30 sec post beginning of hyperventilation (breathing with accelerated frequency e.g. 30/min), 1 minute, 1 ½ minute 2, 2 ½ , 3, , 4, 5 minutes; recovery of this hyperventilation will be followed, for 5 minutes, with the PtCO2, during 3 minutes
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
B1: Healthy subject
Subjects, referred for exercise diagnostic testing, and whose results indicate normal cardiac and pulmonary exercise physiology.
Measurement, throughout these exercise tests, of the alveolar dead space, and its kinetics, up to peak VO2, then during recovery, in the different conditions listed above. Alveolar dead space will be calculated using the continuous Pt CO2 values observed, and also with some intermittent PaCO2 measurement, done as per routine modus operandi (arterialized earlobe capillary drawn at rest, at ventilatory threshold, and at peak exercise). The values measured through PtCO2 and PaCO2 will be compared at these 3 time points.
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
B2: Chronic Obstructive Pulmonary Disease
Measurement, throughout these exercise tests, of the alveolar dead space, and its kinetics, up to peak VO2, then during recovery, in the different conditions listed above. Alveolar dead space will be calculated using the continuous Pt CO2 values observed, and also with some intermittent PaCO2 measurement, done as per routine modus operandi (arterialized earlobe capillary drawn at rest, at ventilatory threshold, and at peak exercise). The values measured through PtCO2 and PaCO2 will be compared at these 3 time points.
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
B3: Interstitial Lung Disease (ILD)
Measurement, throughout these exercise tests, of the alveolar dead space, and its kinetics, up to peak VO2, then during recovery, in the different conditions listed above. Alveolar dead space will be calculated using the continuous Pt CO2 values observed, and also with some intermittent PaCO2 measurement, done as per routine modus operandi (arterialized earlobe capillary drawn at rest, at ventilatory threshold, and at peak exercise). The values measured through PtCO2 and PaCO2 will be compared at these 3 time points.
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
B4: Chronic heart failure (CHF)
Measurement, throughout these exercise tests, of the alveolar dead space, and its kinetics, up to peak VO2, then during recovery, in the different conditions listed above. Alveolar dead space will be calculated using the continuous Pt CO2 values observed, and also with some intermittent PaCO2 measurement, done as per routine modus operandi (arterialized earlobe capillary drawn at rest, at ventilatory threshold, and at peak exercise). The values measured through PtCO2 and PaCO2 will be compared at these 3 time points.
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
B5: Pulmonary Arterial Hypertension (PAH)
Measurement, throughout these exercise tests, of the alveolar dead space, and its kinetics, up to peak VO2, then during recovery, in the different conditions listed above. Alveolar dead space will be calculated using the continuous Pt CO2 values observed, and also with some intermittent PaCO2 measurement, done as per routine modus operandi (arterialized earlobe capillary drawn at rest, at ventilatory threshold, and at peak exercise). The values measured through PtCO2 and PaCO2 will be compared at these 3 time points.
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
B6: inappropriate hyperventilation syndrome
Measurement, throughout these exercise tests, of the alveolar dead space, and its kinetics, up to peak VO2, then during recovery, in the different conditions listed above. Alveolar dead space will be calculated using the continuous Pt CO2 values observed, and also with some intermittent PaCO2 measurement, done as per routine modus operandi (arterialized earlobe capillary drawn at rest, at ventilatory threshold, and at peak exercise). The values measured through PtCO2 and PaCO2 will be compared at these 3 time points.
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
Interventions
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simultaneous determination of PaCO2 and PtCO2
Patients in intensive care, equipped, for their routine clinical management, with an arterial catheter blood line, will have a simultaneous determination of PaCO2 and PtCO2:
* 1\) at rest; 2 arterial CO2/PtCO2 determinations will be carried out, 10 minutes apart
* 2\) During the muscular exercise part of their routine rehabilitation program (whatever it might be, limbs active mobilization, walking, etc...) : several arterial /PtCO2 samples will be collected during the first minutes of their muscular routine: 30 sec, 1 minute, 1 ½ minute, 2, 2 ½ , 3, 4, 5 minutes, 10 minutes (end of exercise). This will generate several couples of blood/transcutaneous CO2 determinations
Hyperventilation test
Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest (0), then 30 sec post beginning of hyperventilation (breathing with accelerated frequency e.g. 30/min), 1 minute, 1 ½ minute 2, 2 ½ , 3, , 4, 5 minutes; recovery of this hyperventilation will be followed, for 5 minutes, with the PtCO2, during 3 minutes
Exercise test
an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
Eligibility Criteria
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Inclusion Criteria
* Either:
Patients in intensive care, conscious and in stable hemodynamic condition, who are already equipped with an arterial line for blood gas analysis (as required by the routine practice in intensive care; no arterial line shall be inserted for the purpose of this study) (Part A1)
Or patients/subjects scheduled for routine cardio-pulmonary exercise testing. Among these, the following patients will be included: COPD, PAH, healthy subjects, hyperventilation, chronic cardiac failure, interstitial lung diseases (ILD) (Part A2 and Part B)
Exclusion Criteria
* Unstable hemodynamics
* Local cutaneous lesion or infection
* Arterial disease such as fistula
* Women with the following condition: pregnancy, breast feeding
* Persons deprived of liberty (according to article L1121-5 to L1121-8 of the French Public Health Code)
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Metropole Savoie
OTHER
Responsible Party
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Locations
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Service de pneumologie
Béthune, , France
Service de pneumologie CHMS
Chambéry, , France
Service de réanimation médicale - CHMS
Chambéry, , France
Service de Pneumologie CHU Grenoble
La Tronche, , France
Countries
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Central Contacts
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Facility Contacts
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Frédéric BART
Role: primary
Serge Kouzan
Role: primary
Bernard AGUILANIU
Role: primary
Other Identifiers
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CHMS18004
Identifier Type: -
Identifier Source: org_study_id
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