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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Chronic Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
simultaneous determination of PaCO2 and PtCO2
Hyperventilation test
Exercise test
Sponsored by
Centre Hospitalier Metropole Savoie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Disease, Chronic Obstructive focused on measuring transcutaneous PtCO2, dead space, exercise test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Service de pneumologie
  • Service de pneumologie CHMSRecruiting
  • Service de réanimation médicale - CHMS
  • Service de Pneumologie CHU Grenoble

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A1: Patient in intensive care

A2: Healthy subjects

B1: Healthy subject

B2: Chronic Obstructive Pulmonary Disease

B3: Interstitial Lung Disease (ILD)

B4: Chronic heart failure (CHF)

B5: Pulmonary Arterial Hypertension (PAH)

B6: inappropriate hyperventilation syndrome

Arm Description

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

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline of Pt CO2 (transcutaneous CO2 partial pressure) measurement together with PaCO2 (arterial partial CO2 pressure)
Part A: serial simultaneous measurements of Pt CO2 (transcutaneous CO2 partial pressure), and PaCO2 (arterial partial CO2 pressure), done during exercise during voluntary hyperventilation
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2018
Last Updated
June 13, 2022
Sponsor
Centre Hospitalier Metropole Savoie
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1. Study Identification

Unique Protocol Identification Number
NCT03718780
Brief Title
Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise
Acronym
TEASE
Official Title
Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Metropole Savoie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Chronic Heart Failure, Pulmonary Arterial Hypertension, Hyperventilation Syndrome, Healthy
Keywords
transcutaneous PtCO2, dead space, exercise test

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1: Patient in intensive care
Arm Type
Experimental
Arm Description
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
Arm Title
A2: Healthy subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
B1: Healthy subject
Arm Type
Experimental
Arm Description
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.
Arm Title
B2: Chronic Obstructive Pulmonary Disease
Arm Type
Experimental
Arm Description
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.
Arm Title
B3: Interstitial Lung Disease (ILD)
Arm Type
Experimental
Arm Description
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.
Arm Title
B4: Chronic heart failure (CHF)
Arm Type
Experimental
Arm Description
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.
Arm Title
B5: Pulmonary Arterial Hypertension (PAH)
Arm Type
Experimental
Arm Description
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.
Arm Title
B6: inappropriate hyperventilation syndrome
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
simultaneous determination of PaCO2 and PtCO2
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Hyperventilation test
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Exercise test
Intervention Description
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 Measure Information:
Title
Change from baseline of Pt CO2 (transcutaneous CO2 partial pressure) measurement together with PaCO2 (arterial partial CO2 pressure)
Description
Part A: serial simultaneous measurements of Pt CO2 (transcutaneous CO2 partial pressure), and PaCO2 (arterial partial CO2 pressure), done during exercise during voluntary hyperventilation
Time Frame
at rest and during exercise/hyperventilation: 30 secondes, 1 minute, 1 ½ minute 2, 2 ½ , 3 , 4, 5 and 10 minutes.
Title
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
Description
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.
Time Frame
continuous measurement: from rest throughout exercise test ( beginning of test, to maximum load (5-10 minutes), then throughout 5 minutes recovery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serge KOUZAN
Phone
0479886118
Email
serge.kouzan@ch-metropole-savoie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien PERNOT
Phone
0479883751
Ext
+33
Email
julien.pernot@ch-metropole-savoie.fr
Facility Information:
Facility Name
Service de pneumologie
City
Béthune
ZIP/Postal Code
62408
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric BART
First Name & Middle Initial & Last Name & Degree
Frédéric BART
Facility Name
Service de pneumologie CHMS
City
Chambéry
ZIP/Postal Code
73000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Kouzan
First Name & Middle Initial & Last Name & Degree
Julien PERNOT
First Name & Middle Initial & Last Name & Degree
Marie COUDURIER
First Name & Middle Initial & Last Name & Degree
Serge KOUZAN
Facility Name
Service de réanimation médicale - CHMS
City
Chambéry
ZIP/Postal Code
73000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc THOURET
Email
Jean-Marc.Thouret@ch-metropole-savoie.fr
First Name & Middle Initial & Last Name & Degree
Vincent PEIGNE
Email
vincent.peigne@ch-metropole-savoie.fr
First Name & Middle Initial & Last Name & Degree
Jean-Marc THOURET
First Name & Middle Initial & Last Name & Degree
Vincent PEIGNE
Facility Name
Service de Pneumologie CHU Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard AGUILANIU
First Name & Middle Initial & Last Name & Degree
Bernard AGUILANIU

12. IPD Sharing Statement

Plan to Share IPD
No

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

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