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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation Non-invasive Ventilation Energy Expenditure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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nocturnal non-invasive ventilation

patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation

Group Type ACTIVE_COMPARATOR

nocturnal non-invasive ventilation

Intervention Type DEVICE

patients will undergo a non-invasive ventilation during the night

no nocturnal non-invasive ventilation

patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nocturnal non-invasive ventilation

patients will undergo a non-invasive ventilation during the night

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

* 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

* acute exacerbation of chronic obstructive pulmonary disease
* severe heart failure
* body-mass-index \>35 m²/kg
* fever

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes