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

Not Applicable

Completed

• Conditions: Non-invasive Ventilation; Metabolism; Energy Expenditure
• Interventions: Device: non-invasive ventilation

• Registration Number: NCT04178694
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2020-01-01
• Status Verified: 2020-04
• Primary Completion: 2020-05-13
• Study Completion: 2020-05-13
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-invasive ventilation	non-invasive ventilation	All subjects will be submitted to non-invasive ventilation with different settings. During the whole period indirect calorimetry will be performed and haemodynamic parameters will be monitored using a non-invasive device. Reversed combined RPE scale will be asked on a regular base.

Primary Outcome Measures

Name	Time	Method
Energy expenditure	during non-invasive ventilation	in kcal/day Energy expenditure will be measured using indirect calorimetry during different settings of non invasive ventilation

Secondary Outcome Measures

Name	Time	Method
reversed combined rate of perceived exertion scale	during non-invasive ventilation	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.
respiratory rate	during non-invasive ventilation	in breaths/min
systolic and diastolic bloodpressure	during non-invasive ventilation	in mmHg
cardiac output	during non-invasive ventilation	in liter/min
CO2 production of the body ( VCO2)	during non-invasive ventilation	in ml/min
O2 consumption of the body (VO2)	during non-invasive ventilation	in ml/min
Respiratory quotient	during non-invasive ventilation	no unit

Trial Locations

Locations (1)

Universitair ziekenhuis Brussel; 🇧🇪 Jette, Brussel, Belgium