Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Endurance capacity
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.
Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.
More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.
Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.
详细描述
Experimental design:
Patients achieving their last pulmonary rehabilitation session will be approached to participate in this study.
Eligible patients who agree to participate in the study and sign informed consent will perform two baseline visit assessments:
First visit: Incremental cardiopulmonary exercise testing. Second visit: Other baseline assessment (see outcome section), including a constant workload exercise testing at 75% of the maximal workload achieved during the incremental exercise testing.
Then, patients will then be randomized to one of the following two arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will be unaware of the patient's allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic obstructive pulmonary disease stage III to IV;
- •With or without long-term oxygen therapy;
- •Having completed a course of pulmonary rehabilitation within the last 4 weeks (at least 18 sessions).
排除标准
- •Did not complete a course of pulmonary rehabilitation;
- •Using noninvasive ventilation or constant positive airway pressure treatment;
- •Tracheostomy;
- •Nasal high flow intolerance;
- •Pregnancy or likely to be;
- •Unable to consent;
- •Patients under guardianship.
结局指标
主要结局
Endurance capacity
时间窗: The endurance capacity will be assessed post-intervention (after 6months)
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
次要结局
- Quality of life: Saint George's Respiratory Questionnaire(The quality of life will be assessed at post-intervention (after 6months))
- Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test(The quality of life will be assessed post-intervention (after 6months))
- Exacerbations(The number of exacerbations will be assessed for a total time frame of 6month)
- Exercise capacity(The distance performed during the six-minute walk test will be assessed post-intervention (after 6months))
- Respiratory muscle function (1) : maximal inspiratory pressure(Maximal inspiratory pressure will be assessed post-intervention (after 6months))
- Hospitalizations(The number of hospitalizations will be assessed for a total time frame of 6month)
- Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day(The time spent during activities superior to 3 metabolic equivalent per day will be assessed during 14 days after 6months of intervention)
- Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area(The quadriceps muscle thickness will be assessed at baseline and post-intervention for a total time frame of 6month)
- Muscle function (2) : bioimpedance(The overall muscle function using bioimpedance will be assessed post-intervention (after 6months))
- Respiratory muscle function (3) : sniff test(Sniff test will be assessed post-intervention (after 6months))
- Quality of sleep (2) : pittsburgh scale(The quality of sleep using the pittsburgh scale will be assessed post-intervention (after 6months))
- Adherence to treatment : hours of utilization per day(The number of hours of utilization per day throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months)
- Respiratory muscle function (2) : maximal expiratory pressure(Maximal expiratory pressure will be assessed post-intervention (after 6months))
- Quality of sleep (1) : Visual Analogue Scale(The quality of sleep using a Visual Analogue Scale will be assessed post-intervention (after 6months))
- Adherence to treatment : days of utilization during the follow-up(The number of days that the nasal high flow device was used throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months)
- Parasternal electromyogram(Parasternal electromyogram will be assessed post-intervention (after 6months))
- Physical activity (1) : steps per day(Steps per day will be assessed during 14 days after 6months of intervention)