Physiologic Effects of Nasal High Flow on Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 6-minute walk test
研究概览
简要总结
This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to consent
- •Age 18 years or older
- •Diagnosis of COPD
- •Ability to ambulate without assistance
- •Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all
排除标准
- •Pregnancy
- •Being on bedrest
- •Inability to consent or cooperate with the study
- •Using of > 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime
- •Hemodynamic instability (resting heart rate > 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)
- •Metal implants in the thoracic regions (pacemakers, Automatic Implantable Cardioverter Defibrillator (AICD), plates, screws, rods, and disc replacements)
研究组 & 干预措施
Nasal High Flow Cannula
Nasal High Flow cannula at 70 liters per minute for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to Nasal Low Flow Cannula at less than or equal to 4 liters per minute with supplemental oxygen for 30 minutes
干预措施: Nasal High Flow Cannula (Device)
Nasal High Flow Cannula
Nasal High Flow cannula at 70 liters per minute for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to Nasal Low Flow Cannula at less than or equal to 4 liters per minute with supplemental oxygen for 30 minutes
干预措施: Nasal Low Flow Cannula (Device)
Nasal Low Flow Cannula
Low Flow Nasal Cannula at less than or equal to 4 liters per minute with supplemental oxygen at patient's baseline for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to High Flow Cannula at 70 liters per minute for 30 minutes
干预措施: Nasal High Flow Cannula (Device)
Nasal Low Flow Cannula
Low Flow Nasal Cannula at less than or equal to 4 liters per minute with supplemental oxygen at patient's baseline for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to High Flow Cannula at 70 liters per minute for 30 minutes
干预措施: Nasal Low Flow Cannula (Device)
结局指标
主要结局
6-minute walk test
时间窗: 30 minutes
The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The distance walked in meters over 6 minutes will be measured.
次要结局
- Breathing measured by the Borg dyspnea scale(30 minutes)
研究者
Saramaria Afanador Castiblanco
Assistant Professor
University of Miami