Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
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Bavaria
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Schoenau Am Koenigssee, Bavaria, Duitsland, 83471
- Werving
- Schoen Klinik Berchtesgadener Land
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Contact:
- Klaus Kenn, Dr.
- Telefoonnummer: +49 8652 931541
- E-mail: kkenn@schoen-kliniken.de
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Hoofdonderzoeker:
- Klaus Kenn, Dr.
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Onderonderzoeker:
- Rainer Gloeckl
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria 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)
Exclusion Criteria for Intervention group:
- acute exacerbation of chronic obstructive pulmonary disease
- severe heart failure
- body-mass-index >35 m²/kg
- fever
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
- fever
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: nocturnal non-invasive ventilation
patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation
|
patients will undergo a non-invasive ventilation during the night
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|
Geen tussenkomst: no nocturnal non-invasive ventilation
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
energy expenditure during night
Tijdsspanne: day 1-3 and day 14-16
|
energy expenditure will be assessed by Sensewear Armband
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day 1-3 and day 14-16
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
energy expenditure during day
Tijdsspanne: day 1-3 and day 14-16
|
energy expenditure will be assessed by SenseWear Armband
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day 1-3 and day 14-16
|
|
lung function
Tijdsspanne: day 1-3 and day 14-16
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measured by a bodyplethysmograph
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day 1-3 and day 14-16
|
|
sleep quality
Tijdsspanne: day 1-3 and day 14-16
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measured by Severe Respiratory Insufficiency Questionnaire
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day 1-3 and day 14-16
|
|
arterial pressure of carbon dioxide during night
Tijdsspanne: day 1-3 and day 14-16
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measured transcutaneously by a Sentec device
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day 1-3 and day 14-16
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|
movement activity during the night
Tijdsspanne: day 1
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night movement activity will be measured in a subgroup with the Dynaport device
|
day 1
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BGL-NIV2
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