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

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01961245
• Other study ID #: BGL-NIV2
• Status: Recruiting
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: Klaus Kenn, Dr.
• Phone: +49 8652 931451
• Email: kkenn[@]schoen-kliniken.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Energy Expenditure
• Lung Diseases
• Lung Diseases, Obstructive
• Non-invasive Ventilation
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

Device:
• nocturnal non-invasive ventilation
patients will undergo a non-invasive ventilation during the night

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schoenau Am Koenigssee	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy expenditure during night	energy expenditure will be assessed by Sensewear Armband	day 1-3 and day 14-16
Secondary	energy expenditure during day	energy expenditure will be assessed by SenseWear Armband	day 1-3 and day 14-16
Secondary	lung function	measured by a bodyplethysmograph	day 1-3 and day 14-16
Secondary	sleep quality	measured by Severe Respiratory Insufficiency Questionnaire	day 1-3 and day 14-16
Secondary	arterial pressure of carbon dioxide during night	measured transcutaneously by a Sentec device	day 1-3 and day 14-16
Secondary	movement activity during the night	night movement activity will be measured in a subgroup with the Dynaport device	day 1