Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- energy expenditure during night
研究概览
简要总结
It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. If non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage IV will be recruited for this study. There will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage IV without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program.
A sub-trial of this study is to validate night movement accuracy of the Dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. This will be performed in study participants as well as in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Intervention group:
- •chronic obstructive pulmonary disease stage IV
- •indication for the use of a nocturnal non-invasive ventilation (according to the German guidelines Schoenhofer et al. 2008)
- •patient has not yet used non-invasive ventilation at all or inadequately (less than 3 hours per day)
排除标准
- •for Intervention group:
- •acute exacerbation of chronic obstructive pulmonary disease
- •severe heart failure
- •body-mass-index >35 m²/kg
- •Inclusion Criteria for control group:
- •chronic obstructive pulmonary disease stage IV (- healthy volunteers are also eligible for the sub-trial of this study to validate night movement accuracy of an activity monitor)
- •Exclusion Criteria for control group:
- •acute exacerbation of chronic obstructive pulmonary disease
- •indication for the use of a non-invasive ventilation
- •severe heart failure
- •body-mass-index >35 m²/kg
研究组 & 干预措施
nocturnal non-invasive ventilation
patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation
干预措施: nocturnal non-invasive ventilation (Device)
no nocturnal non-invasive ventilation
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
结局指标
主要结局
energy expenditure during night
时间窗: day 1-3 and day 14-16
energy expenditure will be assessed by Sensewear Armband
次要结局
- energy expenditure during day(day 1-3 and day 14-16)
- movement activity during the night(day 1)
- lung function(day 1-3 and day 14-16)
- sleep quality(day 1-3 and day 14-16)
- arterial pressure of carbon dioxide during night(day 1-3 and day 14-16)
研究者
Klaus Kenn
Dr.
Schön Klinik Berchtesgadener Land
