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