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Clinical Trials/NCT03718780
NCT03718780
Unknown
Not Applicable

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

Centre Hospitalier Metropole Savoie4 sites in 1 country105 target enrollmentFebruary 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
Centre Hospitalier Metropole Savoie
Enrollment
105
Locations
4
Primary Endpoint
Change from baseline of Pt CO2 (transcutaneous CO2 partial pressure) measurement together with PaCO2 (arterial partial CO2 pressure)
Last Updated
3 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
February 22, 2019
End Date
February 22, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

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

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.

Study Sites (4)

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