Comparing Exercise Capacity in Patients With COPD Using High Flow Nasal Cannula Oxygen vs The Venturi Mask
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Exercise capacity - Maximum Walking Speed Reached
研究概览
简要总结
The aim of this study is to compare exercise capacity in COPD patients through two different systems of supplemental oxygen delivery: High Flow Nasal Cannula Oxygen (HFNCO) and The Venturi Mask (VM).
详细描述
Design: interventional, crossover, randomized.
The main goal of this study is to compare the maximum speed reached in an Incremental Load Treadmill Test (ILTT) and max time tolerated in a Constant Treadmill Load Test (CTLT) while using two different oxygen delivery devices (High Flow Nasal Cannula Oxygen and The Mask Venturi).
Patients will be evaluated through two different kinds of tests: Incremental Load Treadmill Test (ILTT) and Constant Treadmill Load Test (CTLT). Each test will be conducted two times, once using HFNCO and the other time with The VM.
In total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA.
The following variables will be measured before, during and after each 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
- •Long term oxygen therapy (LTOT) or oxygen needs during exercise.
- •Clinically stable defined as four weeks without exacerbation.
排除标准
- •Refusal to participate
- •Any neuromuscular or cardiovascular or condition that limits test performance.
- •Contraindication for exercise
研究组 & 干预措施
High Flow Nasal Cannula Oxygen
- Incremental Load Treadmill Test (ILTT) using HFNCO
- Constant Treadmill Load Test (CTLT) using HFNCO
干预措施: High Flow Nasal Cannula Oxygen (Device)
The Venturi Mask
- Incremental Load Treadmill Test (ILTT) using venturi mask
- Constant Treadmill Load Test (CTLT) using venturi mask
干预措施: The Venturi Mask (Device)
结局指标
主要结局
Exercise capacity - Maximum Walking Speed Reached
时间窗: 2 measurements separated by 48 hs
The exercise capacity test measures the maximum speed (in Km/h) reached during an Incremental Load Treadmill Test (ILTT). The test begins at a speed of 3 km/h and each minute after, we will increase the speed by 0.5 km/h. The patient will walk until he exhausts his capacity, once reached, the test will finished. A second Incremental Load Treadmill Test (ILTT) will be conducted 48 hs afterwards using The Venturi Mask or High Flow Nasal Cannula Oxygen depending on the previous randomization.
Exercise capacity - Maximum Walking Time Reached
时间窗: 2 measurements separated by 48 hs
The exercise capacity test measures the maximum time (in minutes) reached during a Constant Load Treadmill Test (CLTT). The treadmill speed will be constant and set up at 90% of the maximum speed reached in the previous Incremental Load Treadmill Test (ILTT). The patient will walk at the same velocity until he exhausts his capacity thus ending the test. A second Constant Load Treadmill Test (CLTT) will be conducted 48 hs following the first Constant Load Treadmill Test (CLTT) using The Venturi Mask or High Flow Nasal Cannula depending on the previous randomization.
次要结局
未报告次要终点