High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Endurance time
研究概览
简要总结
Objectives:
- To evaluate endurance time during cardiopulmonary exercise test (CPET) performance comparing standard oxygen therapy to high-flow nasal cannula (HFNC) oxygen therapy in subjects with idiopathic pulmonary fibrosis (IPF) with exertional desaturation.
- To assess oxygenation level (peripheral and muscular) as well as dyspnea and fatigue during exercise in IPF subjects with exertional desaturation using oxygen supplementation with HFNC compared with standard oxygen supplementation.
Method: multicenter crossover clinical trial. Patients with IPF presenting oxygen desaturation during the six-minute walking test (6MWT) (SpO2 mean ≤ 85%) will be included consecutively . Each subject evaluated will perform initially an incremental CPET to evaluate the patient's maximum exercise capacity. Supplemental oxygen will be applied to maintain SpO2 >85% with a Venturi mask. Maximum exercise capacity and the appropriate final oxygen inspiratory fraction (FiO2) needed for the following tests will be determined.
Posteriorly each patient will perform two constant load CPET (at 75% of the maximum workload achieved with the incremental CPET); one with standard oxygen therapy and the other one with HFNC oxygen therapy. Endurance time, dyspnea and leg fatigue and oxygen saturation (peripheral and muscular) will be recorded.
Evaluation measures: Endurance time, dyspnea and leg fatigue (Borg scale), and oxygen saturation.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with IPF diagnosis according to the 2018 international consensus guidelines
- •Mean SpO2 ≤ 85% during the 6MWT performed under room air conditions
排除标准
- •Fibrotic interstitial lung diseases other than IPF
- •Chronic obstructive pulmonary disease (COPD)
- •Inability to perform a complete CPET due to osteo-articular or cognitive limitations
- •End-stage lung disease
- •Severe pulmonary hypertension
研究组 & 干预措施
Standard oxygen therapy
干预措施: Oxygen (Drug)
High-flow nasal cannula oxygen therapy
干预措施: Oxygen (Drug)
结局指标
主要结局
Endurance time
时间窗: through study completion, an average of 1 week
Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy
次要结局
- Dyspnea and fatigue(through study completion, an average of 1 week)
- Oxygen saturation(through study completion, an average of 1 week)
- Muscle oxygen saturation (StO2)(through study completion, an average of 1 week)