Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03718780
Status:
UNKNOWN
Last Update Posted:
2022-06-14
First Post:
2018-10-04
Brief Title:
Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise
Sponsor:
Centre Hospitalier Metropole Savoie
Organization:
Centre Hospitalier Metropole Savoie
Study Overview
Official Title:
Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEASE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None