Metabolism Clinical Trial
— GaneshOfficial title:
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
Verified date | April 2020 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | May 13, 2020 |
Est. primary completion date | May 13, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - healthy volunteers Exclusion Criteria: - pregnancy - prisoners - participation in interventional study in last 2 weeks before enrolment - Current ongoing disease: - Cardiac - respiratory - ear - nose - gastro-intestinal - neurological - psychiatric |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair ziekenhuis Brussel | Jette | Brussel |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Energy expenditure | in kcal/day Energy expenditure will be measured using indirect calorimetry during different settings of non invasive ventilation | during non-invasive ventilation | |
Secondary | reversed combined rate of perceived exertion scale | no unit, range: [-10 , +10] based on an existing scale of perceived exertion, a reverse part was added to be able to measure an improvement of respiratory exercise compared to normal state. | during non-invasive ventilation | |
Secondary | respiratory rate | in breaths/min | during non-invasive ventilation | |
Secondary | systolic and diastolic bloodpressure | in mmHg | during non-invasive ventilation | |
Secondary | cardiac output | in liter/min | during non-invasive ventilation | |
Secondary | CO2 production of the body ( VCO2) | in ml/min | during non-invasive ventilation | |
Secondary | O2 consumption of the body (VO2) | in ml/min | during non-invasive ventilation | |
Secondary | Respiratory quotient | no unit | during non-invasive ventilation |
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