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临床试验/NCT02495675
NCT02495675Unknown不适用

Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects

Laval University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Work of breathing

研究概览

简要总结

This study evaluates the work of breathing among healthy subjects under various conditions of treatment with high flow nasal cannulas. Ten subjects will be included. The design of this study is a cross over of five treatment periods with different flow settings.

详细描述

High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in carbone dioxyde arterial pressure. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.

The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing among healthy subjects. The investigators will evaluate the baseline status in room air, and then compare it with four different levels of flow. The primary endpoint will be the work of breathing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •Healthy subjects
  • •Written and informed consent

排除标准

  • •Pregnant or breastfeeding women;
  • •Subject enrolled in another study excluding co-enrolment;
  • •Cardio-vascular or respiratory disease;
  • •History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
  • •Subject feeling nauseous or under recent fed condition (<1h).

研究组 & 干预措施

No flow

No Intervention

Subjects will be spontaneously breathing in room air with no flow.

Conventional flow via nasal prongs

Experimental

Subjects will be breathing with nasal prongs delivering 5 L/min of air (inspired fraction of oxygen: 0.21)

干预措施: Conventional flow via nasal prongs (Device)

High flow nasal cannulas 20 L/min

Experimental

Subjects will be breathing with high flow nasal cannulas delivering 20 L/min with an inspired fraction of oxygen of 0.21.

干预措施: High flow nasal cannulas (Device)

High flow nasal cannulas 40 L/min

Experimental

Subjects will be breathing with high flow nasal cannulas delivering 40 L/min with an inspired fraction of oxygen of 0.21.

干预措施: High flow nasal cannulas (Device)

High flow nasal cannulas 60 L/min

Experimental

Subjects will be breathing with high flow nasal cannulas delivering 60 L/min with an inspired fraction of oxygen of 0.21.

干预措施: High flow nasal cannulas (Device)

结局指标

主要结局

Work of breathing

时间窗: 10 minutes

Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome).

次要结局

  • Heart rate(10 minutes)
  • Blood gases(10 minutes)
  • Comfort of breathing(10 minutes)
  • Tidal Volume(10 minutes)
  • End-tidal carbon dioxide(10 minutes)
  • Dyspnea(10 minutes)
  • Respiratory Rate(10 minutes)
  • Oxygen saturation(10 minutes)
  • Esophageal pressure-time product(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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