Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease (Exercise-NIV)
2019年1月8日 更新者：ADIR Association
Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine wether the interface (facial or nasal mask) influences performance in patients with chronic obstructive pulmonary disease exercising with non-invasive ventilation.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
21
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Bois-Guillaume、フランス
- ADIR Association
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age > 18 years
- Chronic obstructive pulmonary disease Gold III-IV
- Eligible for pulmonary rehabilitation
- Exercise limitation : at least respiratory limitation (ventilatory reserve ≤ 30%)
Non-inclusion Criteria:
- Pregnant woman or likely to be
- Familiar with home non-invasive ventilation
- Patient under guardianship
Exclusion Criteria:
- Acute exacerbation of chronic obstructive pulmonary disease
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CWLT with facial mask
This study has a cross-over design.
Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
|
Every patients will achieve 3 constant work load test (CWLT) at 75% Wpic.
The first CWLT will be realized without any ventilatory support.
The 2 others CWLT will be achieved with non-invasive ventilation support using facial or nasal interface in a randomized order.
|
|
実験的：CWLT with nasal mask
This study has a cross-over design.
Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
|
Every patients will achieve 3 constant work load test (CWLT) at 75% Wpic.
The first CWLT will be realized without any ventilatory support.
The 2 others CWLT will be achieved with non-invasive ventilation support using facial or nasal interface in a randomized order.
|
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 |
|---|---|---|
|
Endurance time (Tlim, in second) during Constant Work Load Test (CWLT).
時間枠：The outcome will be measure after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Patients will achieve 3 Constant Work Load Test Under different conditions (1 without noninvasive ventilation and 2 with noninvasive ventilation using in a randomised order facial or nasal mask).
Endurance time (sec) will be recorded at the end of every test.
|
The outcome will be measure after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation.
時間枠：The outcome will be measure after every CWLT achieved with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
The comfort of the different interfaces is assessed after every CWLT using numerical scale.
|
The outcome will be measure after every CWLT achieved with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
Dyspnea during CWLT using modified Borg Scale (0-10).
時間枠：The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
The dyspnea will be assessed every 30sec during CWLT.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
|
Exhaustion during CWLT using modified Borg Scale (0-10).
時間枠：The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
The exhaustion will be assessed every 30sec during CWLT.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
|
Heart rate (rpm) during CWLT using capnograph.
時間枠：The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
|
Blood pressure (mmHg) before and after every CWLT using electrical blood pressure device.
時間枠：The outcome will be assessed before and after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
The outcome will be assessed before and after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
|
Oxygen saturation (SpO2, %) during CWLT using capnograph.
時間枠：The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
|
Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph.
時間枠：The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
|
Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring.
時間枠：The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring.
時間枠：The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring.
時間枠：The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring.
時間枠：The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：David Debeaumont, MD、CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- スタディチェア：Tristan Bonnevie, PT, MsC、ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
- 主任研究者：Catherine Viacroze, MD、CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年6月1日
一次修了 (実際)
2018年2月1日
研究の完了 (実際)
2018年2月1日
試験登録日
最初に提出
2016年5月30日
QC基準を満たした最初の提出物
2016年6月9日
最初の投稿 (見積もり)
2016年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月9日
QC基準を満たした最後の更新が送信されました
2019年1月8日
最終確認日
2019年1月1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
- Exercise-NIV
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。