Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Non-invasive Ventilation
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
nocturnal non-invasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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
Sites / Locations
- Schoen Klinik Berchtesgadener LandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
nocturnal non-invasive ventilation
no nocturnal non-invasive ventilation
Arm Description
patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
Outcomes
Primary Outcome Measures
energy expenditure during night
energy expenditure will be assessed by Sensewear Armband
Secondary Outcome Measures
energy expenditure during day
energy expenditure will be assessed by SenseWear Armband
lung function
measured by a bodyplethysmograph
sleep quality
measured by Severe Respiratory Insufficiency Questionnaire
arterial pressure of carbon dioxide during night
measured transcutaneously by a Sentec device
movement activity during the night
night movement activity will be measured in a subgroup with the Dynaport device
Full Information
NCT ID
NCT01961245
First Posted
September 30, 2013
Last Updated
February 26, 2019
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT01961245
Brief Title
Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Non-invasive Ventilation, Energy Expenditure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nocturnal non-invasive ventilation
Arm Type
Active Comparator
Arm Description
patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation
Arm Title
no nocturnal non-invasive ventilation
Arm Type
No Intervention
Arm Description
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
Intervention Type
Device
Intervention Name(s)
nocturnal non-invasive ventilation
Intervention Description
patients will undergo a non-invasive ventilation during the night
Primary Outcome Measure Information:
Title
energy expenditure during night
Description
energy expenditure will be assessed by Sensewear Armband
Time Frame
day 1-3 and day 14-16
Secondary Outcome Measure Information:
Title
energy expenditure during day
Description
energy expenditure will be assessed by SenseWear Armband
Time Frame
day 1-3 and day 14-16
Title
lung function
Description
measured by a bodyplethysmograph
Time Frame
day 1-3 and day 14-16
Title
sleep quality
Description
measured by Severe Respiratory Insufficiency Questionnaire
Time Frame
day 1-3 and day 14-16
Title
arterial pressure of carbon dioxide during night
Description
measured transcutaneously by a Sentec device
Time Frame
day 1-3 and day 14-16
Title
movement activity during the night
Description
night movement activity will be measured in a subgroup with the Dynaport device
Time Frame
day 1
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Kenn, Dr.
Phone
+49 8652 931451
Email
kkenn@schoen-kliniken.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Gloeckl
Phone
+49 8652 931630
Email
rgloeckl@schoen-kliniken.de
Facility Information:
Facility Name
Schoen Klinik Berchtesgadener Land
City
Schoenau Am Koenigssee
State/Province
Bavaria
ZIP/Postal Code
83471
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr.
Phone
+49 8652 931541
Email
kkenn@schoen-kliniken.de
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr.
First Name & Middle Initial & Last Name & Degree
Rainer Gloeckl
12. IPD Sharing Statement
Learn more about this trial
Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
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