Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT04178694
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2019-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Study Overview
Official Title:
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
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:
Ganesh
Brief Summary:
Before inclusion in the trial. Careful medical history and medication use will be asked. Once included, 5 healthy subjects non-invasive ventilation(V60, Philips, Eindhoven, The Netherlands) will be administered at a level of positive end expiratory pressure (PEEP) of 4 cmH2O and without additional inspiratory support. Inspiratory support will then increase by 2 cmH2O every 2 minutes until 8 cmH2O is achieved for 2 minutes. The energy expenditure is measured using indirect calorimetry (Q-NRG®, Cosmed, Italy). To measure respiratory effort, the reversed RPE-scale was created for the purpose of the study. It uses the validated "rate of perceived exertion" scale (RPE-scale) which was altered by adding a reversed part. This could result in a score of -10 (no respiratory effort) until +10 ( maximal respiratory effort) where 0 represents the basal respiratory condition. Monitoring of heart rate, blood pressure and cardiac output will be done ( Nexfin®, BMEYE, Amsterdam, The Netherlands).
After termination of the study clinical observation by principal investigator or co-investigator will be done for 15 minutes or until all side effects have worn off. If no side effects are observed, subjects will be released.
After termination of the study clinical observation by principal investigator or co-investigator will be done for 15 minutes or until all side effects have worn off. If no side effects are observed, subjects will be released.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: