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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Klaus Kenn, Dr.
- 電話番号:+49 8652 931451
- メール:kkenn@schoen-kliniken.de
研究連絡先のバックアップ
- 名前:Rainer Gloeckl
- 電話番号:+49 8652 931630
- メール:rgloeckl@schoen-kliniken.de
研究場所
-
-
Bavaria
-
Schoenau Am Koenigssee、Bavaria、ドイツ、83471
- 募集
- Schoen Klinik Berchtesgadener Land
-
コンタクト:
- Klaus Kenn, Dr.
- 電話番号:+49 8652 931541
- メール:kkenn@schoen-kliniken.de
-
主任研究者:
- Klaus Kenn, Dr.
-
副調査官:
- Rainer Gloeckl
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:nocturnal non-invasive ventilation
patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation
|
patients will undergo a non-invasive ventilation during the night
|
介入なし:no nocturnal non-invasive ventilation
patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
energy expenditure during night
時間枠:day 1-3 and day 14-16
|
energy expenditure will be assessed by Sensewear Armband
|
day 1-3 and day 14-16
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
energy expenditure during day
時間枠:day 1-3 and day 14-16
|
energy expenditure will be assessed by SenseWear Armband
|
day 1-3 and day 14-16
|
lung function
時間枠:day 1-3 and day 14-16
|
measured by a bodyplethysmograph
|
day 1-3 and day 14-16
|
sleep quality
時間枠:day 1-3 and day 14-16
|
measured by Severe Respiratory Insufficiency Questionnaire
|
day 1-3 and day 14-16
|
arterial pressure of carbon dioxide during night
時間枠:day 1-3 and day 14-16
|
measured transcutaneously by a Sentec device
|
day 1-3 and day 14-16
|
movement activity during the night
時間枠:day 1
|
night movement activity will be measured in a subgroup with the Dynaport device
|
day 1
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BGL-NIV2
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。