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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Bavaria
-
Schoenau Am Koenigssee, Bavaria, Tyskland, 83471
- Rekruttering
- Schoen Klinik Berchtesgadener Land
-
Kontakt:
- Klaus Kenn, Dr.
- Telefonnummer: +49 8652 931541
- E-mail: kkenn@schoen-kliniken.de
-
Ledende efterforsker:
- Klaus Kenn, Dr.
-
Underforsker:
- Rainer Gloeckl
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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
|
|
Ingen indgriben: no nocturnal non-invasive ventilation
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
energy expenditure during night
Tidsramme: day 1-3 and day 14-16
|
energy expenditure will be assessed by Sensewear Armband
|
day 1-3 and day 14-16
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
energy expenditure during day
Tidsramme: day 1-3 and day 14-16
|
energy expenditure will be assessed by SenseWear Armband
|
day 1-3 and day 14-16
|
|
lung function
Tidsramme: day 1-3 and day 14-16
|
measured by a bodyplethysmograph
|
day 1-3 and day 14-16
|
|
sleep quality
Tidsramme: day 1-3 and day 14-16
|
measured by Severe Respiratory Insufficiency Questionnaire
|
day 1-3 and day 14-16
|
|
arterial pressure of carbon dioxide during night
Tidsramme: day 1-3 and day 14-16
|
measured transcutaneously by a Sentec device
|
day 1-3 and day 14-16
|
|
movement activity during the night
Tidsramme: day 1
|
night movement activity will be measured in a subgroup with the Dynaport device
|
day 1
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BGL-NIV2
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