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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
85
patients will undergo a non-invasive ventilation during the night
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, Germany
RECRUITINGenergy expenditure during night
energy expenditure will be assessed by Sensewear Armband
Time frame: day 1-3 and day 14-16
energy expenditure during day
energy expenditure will be assessed by SenseWear Armband
Time frame: day 1-3 and day 14-16
lung function
measured by a bodyplethysmograph
Time frame: day 1-3 and day 14-16
sleep quality
measured by Severe Respiratory Insufficiency Questionnaire
Time frame: day 1-3 and day 14-16
arterial pressure of carbon dioxide during night
measured transcutaneously by a Sentec device
Time frame: day 1-3 and day 14-16
movement activity during the night
night movement activity will be measured in a subgroup with the Dynaport device
Time frame: day 1
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