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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bavaria
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Schoenau Am Koenigssee, Bavaria, 독일, 83471
- 모병
- Schoen Klinik Berchtesgadener Land
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연락하다:
- Klaus Kenn, Dr.
- 전화번호: +49 8652 931541
- 이메일: kkenn@schoen-kliniken.de
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수석 연구원:
- Klaus Kenn, Dr.
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부수사관:
- Rainer Gloeckl
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: nocturnal non-invasive ventilation
patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation
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patients will undergo a non-invasive ventilation during the night
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간섭 없음: no nocturnal non-invasive ventilation
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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energy expenditure during night
기간: day 1-3 and day 14-16
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energy expenditure will be assessed by Sensewear Armband
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day 1-3 and day 14-16
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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energy expenditure during day
기간: day 1-3 and day 14-16
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energy expenditure will be assessed by SenseWear Armband
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day 1-3 and day 14-16
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lung function
기간: day 1-3 and day 14-16
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measured by a bodyplethysmograph
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day 1-3 and day 14-16
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sleep quality
기간: day 1-3 and day 14-16
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measured by Severe Respiratory Insufficiency Questionnaire
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day 1-3 and day 14-16
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arterial pressure of carbon dioxide during night
기간: day 1-3 and day 14-16
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measured transcutaneously by a Sentec device
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day 1-3 and day 14-16
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movement activity during the night
기간: day 1
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night movement activity will be measured in a subgroup with the Dynaport device
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day 1
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BGL-NIV2
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