跳至主要内容
临床试验/NCT01961245
NCT01961245Unknown不适用

Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease

Schön Klinik Berchtesgadener Land1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

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

Active Comparator

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

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Klaus Kenn

Dr.

Schön Klinik Berchtesgadener Land

研究点 (1)

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