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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Energy Expenditure; Non-invasive Ventilation
• Intervention / Treatment: Device: nocturnal non-invasive ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaus Kenn, Dr.; Phone Number: +49 8652 931451; Email: kkenn@schoen-kliniken.de
• Study Contact Backup: Name: Rainer Gloeckl; Phone Number: +49 8652 931630; Email: rgloeckl@schoen-kliniken.de

Study Locations

• Germany
  • Bavaria
    • Schoenau Am Koenigssee, Bavaria, Germany, 83471
      • Recruiting
      • Schoen Klinik Berchtesgadener Land
      • Contact: Klaus Kenn, Dr.; Phone Number: +49 8652 931541; Email: kkenn@schoen-kliniken.de
      • Principal Investigator: Klaus Kenn, Dr.
      • Sub-Investigator: Rainer Gloeckl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nocturnal non-invasive ventilation; patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation	Device: nocturnal non-invasive ventilation; patients will undergo a non-invasive ventilation during the night
No Intervention: no nocturnal non-invasive ventilation; patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
energy expenditure during night	energy expenditure will be assessed by Sensewear Armband	day 1-3 and day 14-16

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BGL-NIV2