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

Metabolism Clinical Trial

— Ganesh  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178694
• Other study ID #: B.U.N. 143201940980
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 13, 2020

Study information

• Verified date: April 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Energy Expenditure
• Metabolism
• Non-invasive Ventilation

Intervention

Device:
• non-invasive ventilation
non-invasive ventilation will be performed on every subjects

Locations

Country	Name	City	State
Belgium	Universitair ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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