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The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers

The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04178694
Acronym
Ganesh
Enrollment
5
Registered
2019-11-26
Start date
2020-01-01
Completion date
2020-05-13
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Energy Expenditure, Metabolism, Non-invasive Ventilation

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.

Interventions

DEVICEnon-invasive ventilation

non-invasive ventilation will be performed on every subjects

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Energy expenditureduring non-invasive ventilationin kcal/day Energy expenditure will be measured using indirect calorimetry during different settings of non invasive ventilation

Secondary

MeasureTime frameDescription
respiratory rateduring non-invasive ventilationin breaths/min
systolic and diastolic bloodpressureduring non-invasive ventilationin mmHg
cardiac outputduring non-invasive ventilationin liter/min
reversed combined rate of perceived exertion scaleduring non-invasive ventilationno 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.
O2 consumption of the body (VO2)during non-invasive ventilationin ml/min
Respiratory quotientduring non-invasive ventilationno unit
CO2 production of the body ( VCO2)during non-invasive ventilationin ml/min

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026