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

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.

Study Overview

• Status: Completed
• Conditions: Energy Expenditure; Metabolism; Non-invasive Ventilation
• Intervention / Treatment: Device: non-invasive ventilation

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: non-invasive ventilation; non-invasive ventilation will be performed on every subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
respiratory rate	in breaths/min	during non-invasive ventilation
systolic and diastolic bloodpressure	in mmHg	during non-invasive ventilation
cardiac output	in liter/min	during non-invasive ventilation
CO2 production of the body ( VCO2)	in ml/min	during non-invasive ventilation
O2 consumption of the body (VO2)	in ml/min	during non-invasive ventilation
Respiratory quotient	no unit	during non-invasive ventilation

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Joop Jonckheer, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): May 13, 2020
• Study Completion (ACTUAL): May 13, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (ACTUAL): November 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B.U.N. 143201940980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No