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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
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Bavaria
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Schoenau Am Koenigssee, Bavaria, Alemania, 83471
- Reclutamiento
- Schoen Klinik Berchtesgadener Land
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Contacto:
- Klaus Kenn, Dr.
- Número de teléfono: +49 8652 931541
- Correo electrónico: kkenn@schoen-kliniken.de
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Investigador principal:
- Klaus Kenn, Dr.
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Sub-Investigador:
- Rainer Gloeckl
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
|
|
Sin intervención: no nocturnal non-invasive ventilation
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
energy expenditure during night
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
energy expenditure during day
Periodo de tiempo: day 1-3 and day 14-16
|
energy expenditure will be assessed by SenseWear Armband
|
day 1-3 and day 14-16
|
|
lung function
Periodo de tiempo: day 1-3 and day 14-16
|
measured by a bodyplethysmograph
|
day 1-3 and day 14-16
|
|
sleep quality
Periodo de tiempo: day 1-3 and day 14-16
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measured by Severe Respiratory Insufficiency Questionnaire
|
day 1-3 and day 14-16
|
|
arterial pressure of carbon dioxide during night
Periodo de tiempo: day 1-3 and day 14-16
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measured transcutaneously by a Sentec device
|
day 1-3 and day 14-16
|
|
movement activity during the night
Periodo de tiempo: day 1
|
night movement activity will be measured in a subgroup with the Dynaport device
|
day 1
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BGL-NIV2
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