Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects (HDWOBSS)
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Quebec
-
Québec、Quebec、加拿大、G1V4G5
- 招聘中
- Centre de recherche de l'IUCPQ
-
接触：
- François Lellouche, MD, PhD
- 电话号码：3298 418-656-8711
- 邮箱：francois.lellouche@criucpq.ulaval.ca
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy subjects
- Written and informed consent
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：No flow
Subjects will be spontaneously breathing in room air with no flow.
|
|
|
实验性的：Conventional flow via nasal prongs
Subjects will be breathing with nasal prongs delivering 5 L/min of air (inspired fraction of oxygen: 0.21)
|
Low flow of air delivered through conventional nasal prongs
|
|
实验性的：High flow nasal cannulas 20 L/min
Subjects will be breathing with high flow nasal cannulas delivering 20 L/min with an inspired fraction of oxygen of 0.21.
|
Comparison of different flow levels
其他名称：
|
|
实验性的：High flow nasal cannulas 40 L/min
Subjects will be breathing with high flow nasal cannulas delivering 40 L/min with an inspired fraction of oxygen of 0.21.
|
Comparison of different flow levels
其他名称：
|
|
实验性的：High flow nasal cannulas 60 L/min
Subjects will be breathing with high flow nasal cannulas delivering 60 L/min with an inspired fraction of oxygen of 0.21.
|
Comparison of different flow levels
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Work of breathing
大体时间：10 minutes
|
Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome).
|
10 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Esophageal pressure-time product
大体时间：10 minutes
|
Measured at the end of each period
|
10 minutes
|
|
Tidal Volume
大体时间：10 minutes
|
Measured at the end of each period
|
10 minutes
|
|
Comfort of breathing
大体时间：10 minutes
|
Subjective evaluation at the end of each period
|
10 minutes
|
|
Blood gases
大体时间：10 minutes
|
Arterial or capillary blood gases at the end of each period
|
10 minutes
|
|
Dyspnea
大体时间：10 minutes
|
Evaluation on a borg scale at the end of each period
|
10 minutes
|
|
Respiratory Rate
大体时间：10 minutes
|
Measured at the end of each period
|
10 minutes
|
|
End-tidal carbon dioxide
大体时间：10 minutes
|
Measured at the end of each period
|
10 minutes
|
|
Heart rate
大体时间：10 minutes
|
Measured at the end of each period
|
10 minutes
|
|
Oxygen saturation
大体时间：10 minutes
|
Measured at the end of each period
|
10 minutes
|
合作者和调查者
调查人员
- 研究主任：François Lellouche, MD, PhD、Fondation IUCPQ
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.