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

Study Overview
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Brief Summary
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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.

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

Conditions
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Energy Expenditure, Non-invasive Ventilation, Metabolism

Intervention / Treatment
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* Device: non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-invasive ventilation<br>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<br>* non-invasive ventilation will be performed on every subjects<br>|

What is the study measuring?
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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 |