Lung Volume Reduction Via Coils in Patients With COPD
Impact of Endoscopic Lung Volume Reduction Via Coils on Inspiratory Muscle Strength in Patients With COPD
For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the insertion of the coils distended lung sections shrink so that healthy parts can expand.
In the present study investigators intend to examine, whether the insertion of the coils improves diaphragm function and force of the breathing muscles. Investigators hypothesize that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.
調査の概要
状態
詳細な説明
In line with routine explorations it is necessary to clarify whether a patient is suitable for the endoscopic lung volume reduction. To address this question lung function diagnostics, 6-minutes-walk-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and transthoracic echocardiography have to be performed.
After confirmation of the suitability for the endoscopic lung volume reduction patients who fulfill all other eligibility criteria will be educated about the aim and performance of the study by an investigator. After reading the patient information patient may submit his informed written consent. After that information on the risks will be given by a treating physician.
Following examination will be performed additional due to the study: determination of the strength of breathing muscles, determination of the life quality index via St.-George-questionary and determination of the depression score via SF-8-questionary (short form-8).
After that coils will be implanted and a permanent post-operative examination will be performed for 24 hours.
Three, respectively nine month after the implanting follow up exploration will be performed on the study patients.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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-
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Aachen、ドイツ、52074
- 募集
- RWTH Univerity Hospital MK1
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コンタクト：
- Michael Dreher, Univ.-Prof.
- 電話番号：+492418088763
- メール：mdreher@ukaachen.de
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コンタクト：
- Tobias Müller, PD Dr.med.
- 電話番号：+492418088763
- メール：tobmueller@ukaachen.de
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- bilateral lung emphysema after CT with sufficient amount of tissue to perform RePneu Coil implantation at the discretion of the treating physicians
- homogeneous or heterogeneous emphysema
- previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal infections and seasonal influenza)
- nicotine abstention for not less than three months, documented by CO-HB (haemoglobin) < 2%
- FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value, after bronchodilatation
- total lung capacity (TLC) ≥ 100% of reference value
- residual volume (RV) ≥ 175% of reference value
- patient's suitability for endoscopic lung volume reduction according to multidisciplinary decision of pneumology and thorax surgery division.
- signed Informed Consent
- understanding of the nature, significance and implications of the study
- ability to understand and follow instructions of the study stuff
Exclusion Criteria:
- echo-cardiographic right ventricular pressure (PAPsys) > 50 mmHg
- indication for a permanent anticoagulation therapy (besides ASS)
- pulmonal cachexia
- pregnancy and lactating
- permanent treatment with > 20 mg Prednison per day
- hospitalisation due to a COPD-exacerbation in the last 3 months
- > 3 steroid-treated exacerbations in the last year
- Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation
- severe diffusion impairment (DLCO < 20%)
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
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 |
|---|---|---|
|
breathing strength
時間枠：Change of breathing strength 3 (respectively 9) months after the bronchoscopy
|
Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1)
Sniff nasal pressure
|
Change of breathing strength 3 (respectively 9) months after the bronchoscopy
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael Dreher, Univ.-Prof.、RWTH University Hospital MK1
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
- 14-001
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。