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Trial record 18 of 667 for:    CARBON DIOXIDE AND arterial

Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise (TEASE)

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ClinicalTrials.gov Identifier: NCT03718780
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Metropole Savoie

Brief Summary:

The study aim is to monitor, during exercise tests carried out in various conditions, the alveolar dead space, by means of continuous transcutaneous measurement of Pt CO2, which would be used as a surrogate for arterial PaCO2. Validity of this measurement needs to be assessed against arterial sampling (either arterial, or arterialized capillary), especially with regards to the lag time required by the CO2 diffusion from the arterial compartment (PaCO2) to the cutaneous one (PtCO2), in particular when rapid changes of CO2 might be induced by exercise.

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)


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Chronic Heart Failure Pulmonary Arterial Hypertension Hyperventilation Syndrome Healthy Other: simultaneous determination of PaCO2 and PtCO2 Other: Hyperventilation test Other: Exercise test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise.
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: 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

Other: 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

Experimental: 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.

Other: 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

Other: 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

Experimental: 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.

Other: 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

Experimental: 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.
Other: 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

Experimental: 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.
Other: 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

Experimental: 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.
Other: 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

Experimental: 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.
Other: 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

Experimental: 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.
Other: 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




Primary Outcome Measures :
  1. Change from baseline of Pt CO2 (transcutaneous CO2 partial pressure) measurement together with PaCO2 (arterial partial CO2 pressure) [ Time Frame: at rest and during exercise/hyperventilation: 30 secondes, 1 minute, 1 ½ minute 2, 2 ½ , 3 , 4, 5 and 10 minutes. ]

    Part A: serial simultaneous measurements of Pt CO2 (transcutaneous CO2 partial pressure), and PaCO2 (arterial partial CO2 pressure), done

    1. during exercise
    2. during voluntary hyperventilation

  2. Change from baseline by means of continuous measurement of alveolar dead space (VD/VT=(PaCO2-PECO2) /PaCO2), expressed as a percentage from 0% to 100 %) , during exercise test, in different clinical settings [ Time Frame: continuous measurement: from rest throughout exercise test ( beginning of test, to maximum load (5-10 minutes), then throughout 5 minutes recovery. ]

    Part B: change from baseline with continuous alveolar dead space ( (VD/VT=(PaCO2-PECO2) /PaCO2), expressed as percentage from 0 to 100%) variation measurement, during exercise and recovery, in:

    • healthy subject
    • different patient categories: COPD at different stages, pulmonary artery hypertension, hyperventilation syndrome, cardiac failure, Interstitial Lung Disease). Establish patterns seen in these different conditions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written and informed consent, and assent where required.
  • 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:

  • Non-French speaking patients/subjects
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718780


Contacts
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Contact: Serge KOUZAN 0479886118 serge.kouzan@ch-metropole-savoie.fr
Contact: Julien PERNOT 0479883751 ext +33 julien.pernot@ch-metropole-savoie.fr

Locations
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France
Service de pneumologie Not yet recruiting
Béthune, France, 62408
Contact: Frédéric BART         
Principal Investigator: Frédéric BART         
Service de pneumologie CHMS Recruiting
Chambéry, France, 73000
Contact: Serge Kouzan         
Sub-Investigator: Julien PERNOT         
Sub-Investigator: Marie COUDURIER         
Principal Investigator: Serge KOUZAN         
Service de réanimation médicale - CHMS Not yet recruiting
Chambéry, France, 73000
Contact: Jean-Marc THOURET       Jean-Marc.Thouret@ch-metropole-savoie.fr   
Contact: Vincent PEIGNE       vincent.peigne@ch-metropole-savoie.fr   
Sub-Investigator: Jean-Marc THOURET         
Principal Investigator: Vincent PEIGNE         
Service de Pneumologie CHU Grenoble Not yet recruiting
La Tronche, France, 38700
Contact: Bernard AGUILANIU         
Principal Investigator: Bernard AGUILANIU         
Sponsors and Collaborators
Centre Hospitalier Metropole Savoie

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Responsible Party: Centre Hospitalier Metropole Savoie
ClinicalTrials.gov Identifier: NCT03718780     History of Changes
Other Study ID Numbers: CHMS18004
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Metropole Savoie:
transcutaneous PtCO2
dead space
exercise test
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Hyperventilation
Lung Diseases, Interstitial
Hypertension
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms