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

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Metabolism; Non-invasive Ventilation; Energy Expenditure

Treatments: Device: non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04178694

B.U.N. 143201940980

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

non-invasive ventilation

Experimental group

Description:

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.

Treatment:

Device: non-invasive ventilation