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

NCT04178694 | Completed

• 1 other identifier: B.U.N. 143201940980
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy Expenditure; Non-invasive Ventilation; Metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• reversed combined rate of perceived exertion scale

  during non-invasive ventilation

• respiratory rate

  during non-invasive ventilation

• systolic and diastolic bloodpressure

  during non-invasive ventilation

• cardiac output

  during non-invasive ventilation

• CO2 production of the body ( VCO2)

  during non-invasive ventilation

Study Arms (1)

non-invasive ventilation

EXPERIMENTAL

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.

Device: non-invasive ventilation

Interventions

non-invasive ventilation DEVICE

non-invasive ventilation will be performed on every subjects

non-invasive ventilation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

• pregnancy
• prisoners
• participation in interventional study in last 2 weeks before enrolment
• Current ongoing disease:
• Cardiac
• respiratory
• ear
• nose
• gastro-intestinal
• neurological
• psychiatric

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Joop Jonckheer, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 26, 2019
• Study Start: January 1, 2020
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)