Efficacy of Exercise Training With Humified High Flow Nasal Cannula, in Patients With Chronic Obstructive Pulmonary Disease Already in Nocturnal Non-Invasive Ventilation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline in 6MWD
研究概览
简要总结
Humidified High Flow Nasal Cannula (HHFNC), with optional supplemental oxygen delivery, has evolved in recent years with an increasing number of papers that show a better meet with respiratory demand, decrease oxygen dilution, increased Functional Residual Capacity (FRC), dead space washout, more tolerate than Non Invasive Ventilation (NIV) and provide heated and humidified gas. HHFNC is mainly used in intensive care settings or in acute respiratory diseases for the treatment of mild to moderate acute hypoxic respiratory failure and ventilator weaning. The aim of this study is to evaluate, in patients with Chronic Obstructive Pulmonary Disease (COPD) in nocturnal NIV, according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines, whether HHFNC during rehabilitation has an additional effect in increasing the distance in 6 Minute Walking Distance (6MWD) compared to the control group with nocturnal NIV without HHFNC treatment. As secondary objectives, we expect a decrease in Emergency Department (ED) accesses, General Practitioner (GP) unplanned visits, hospitalizations and an improvement of the quality of life and patient satisfaction.
详细描述
RECRUITMENT PHASE: A qualified physiotherapist will check patient lists daily with the aim of identifying suitable candidates for the study.
The patients will be enrolled from January 2020 till june 2021 and they will be stratified individually and randomized by a dedicated software (https://www.randomizer.org/) into two groups:
- Experimental group - Chronic Obstructive Pulmonary Disease (COPD) patients in nocturnal Non Invasive Ventilation (NIV) underwent to respiratory rehabilitation with Humidified High Flow Nasal Cannula (HHFNC) with / without Oxygen Therapy (O2), according to medical prescription;
- Control group - patients in nocturnal NIV underwent to respiratory rehabilitation without HFNC with / without O2, according to medical prescription.
Before randomization, individual clinical inclusion and exclusion criteria will be taken into account in relation to the ability of each patient to tolerate the administration of the high flow ventilation program foreseen by the study.
RUN IN PHASE: After the assessment, each patient will perform a training session prior to the cycle ergometer, during which the subject will work on the workload and the established flow. The intensity of the workload will be 60-80% of the Wmax, calculated with the Hill's formula:
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
- None
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
- •Diagnosis of Chronic Obstructive Pulmonary Disease (post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) <0.7) ;
- •Nocturnal Non Invasive Ventilation (NIV) prescription according to ATS/ERS guidelines with or without long-term oxygen therapy;
- •Clinical stability (no exacerbation and no changing in respiratory drugs in the last 7 days);
排除标准
- •Orthopedic or neurological pathologies that limit physical performance;
- •Cognitive impairment (Mini-Mental State Examination <24);
- •Advanced heart disease, pulmonary fibrosis, participation in other clinical studies in the six months preceding the start of the study.
结局指标
主要结局
Change from baseline in 6MWD
时间窗: "Baseline ( pre-intervention)" and "Immediately after the intervention".
The first outcome we expect to find is a change in the distance at 6-Minute Walking Distance (6MWD).
次要结局
- Number of Exacerbations, GP visits and admission to ED and ICU(Through study completion, an average of 1 year.)