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临床试验/NCT04178694
NCT04178694已完成不适用

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

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Energy expenditure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers

排除标准

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

结局指标

主要结局

Energy expenditure

时间窗: during non-invasive ventilation

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

次要结局

  • 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)
  • O2 consumption of the body (VO2)(during non-invasive ventilation)
  • Respiratory quotient(during non-invasive ventilation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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