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Completed

NCT Number: NCT04178694

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive ventilation

Device

non-invasive ventilation will be performed on every subjects

Primary outcomes

  1. Energy expenditure

    Time frame: during non-invasive ventilation

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

Secondary outcomes

  1. reversed combined rate of perceived exertion scale

    Time frame: 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.

  2. respiratory rate

    Time frame: during non-invasive ventilation

    in breaths/min

  3. systolic and diastolic bloodpressure

    Time frame: during non-invasive ventilation

    in mmHg

  4. cardiac output

    Time frame: during non-invasive ventilation

    in liter/min

  5. CO2 production of the body ( VCO2)

    Time frame: during non-invasive ventilation

    in ml/min

  6. O2 consumption of the body (VO2)

    Time frame: during non-invasive ventilation

    in ml/min

  7. Respiratory quotient

    Time frame: during non-invasive ventilation

    no unit

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Acronym: Ganesh

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2019
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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