NCT05372926招募中不适用
Evaluation of the Physiological Effects of High Flow Nasal Canulae Oxygen Therapy During Exercise in Patients With Fibrosing Interstitial Lung Diseases
ADIR Association2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Ptdi swing
研究概览
简要总结
in this study, the investigators aim to describe the effects of highflow nasal canulae oxygen therapy (HFNC) on respiratory muscle function during exercise in patients with fibrosing interstitial lung diseases (ILD) during an endurance test
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cared for as part of a respiratory rehabilitation program (ADIR association)
- •Presenting diffuse fibrosing interstitial pneumonitis, documented by CT scan data and whatever its etiology
- •Presenting severe hypoxemia in ambient air (SpO2<90%) during an exercise test (6-minute walk test or functional exercise test)
排除标准
- •Patient with a contraindication to carrying out a respiratory rehabilitation program
- •Patient having presented an exacerbation of PID, pneumothorax or pneumomediastinum in the 3 months preceding potential inclusion
- •Tracheostomized patient
- •Patient with a contraindication to the placement of a nasogastric tube
- •Pregnant or breastfeeding women or women of childbearing age without effective means of contraception (a pregnancy test will be carried out)
- •Protected adult patient (guardianship or curatorship)
- •Patient deprived of liberty by court or administrative decision
- •Refusal of patient participation or consent
结局指标
主要结局
Ptdi swing
时间窗: during the intervention, at isotime
To compare the change in transdiaphragmatic pressure between baseline and peak during inspiration (Ptdi swing) between HFNC and VM in patients with fibrosing Interstitial Lung Disease in stable state, at isotime.
次要结局
- DeltaPtdi/DeltaEAdi(during the intervention, at isotime)
- PTPdi(during the intervention, at isotime)
- Poeso swing(during the intervention, at isotime)
- Tlim(during the intervention, at the end of endurance test)
- TcCO2(during the intervention, at isotime)
- PTPoeso(during the intervention, at isotime)
- SmO2(during the intervention, at isotime)
研究者
研究点 (2)
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