Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope
Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound
調査の概要
詳細な説明
Linear endobronchial ultrasound (EBUS) now plays a crucial role in the diagnosis, staging, and treatment planning of lung cancer. Most centers perform linear EBUS via the oral route given the larger diameter of the bronchoscope used. However, the feasibility and the diagnostic accuracy of linear EBUS performed through the nose have not been reported. Furthermore, the two routes of insertion have never been compared in terms of patient satisfaction and comfort.
In order to compare the two routes of insertion, consecutive patients referred for a linear endobronchial ultrasound will be recruited. Participants will be randomized to either oral or nasal insertion. All participants will be sedated and will receive local anesthetics in a similar manner. After the procedure, patients will fill a questionnaire regarding their comfort and satisfaction with the procedure.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Quebec
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Québec、Quebec、カナダ、G1V 4G5
- Institut Universitaire de cardiologie et de pneumologie de Quebec
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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
説明
Inclusion Criteria:
- patients older than 18 years of age
- patients referred for a first linear endobronchial ultrasound
Exclusion Criteria:
- Patients who previously underwent an EBUS
- Patients intubated with an endotracheal tube
- Patients under the age of 18
- Patients unable to provide informed consent
- Patients currently taking anticoagulants (therapeutic doses of intravenous or subcutaneous heparin, low-molecular weight heparins, direct thrombin inhibitors or other agents)
- Patients taking anti-platelet therapy other than aspirin (clopidogrel, ticagrelor, prasugrel). A period of 7 days off medication is required before participation.
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：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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他の：Nasal EBUS insertion
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose.
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|
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他の：Oral EBUS insertion
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth.
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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 |
|---|---|---|
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Patient comfort and satisfaction
時間枠：Two hours after endobronchial ultrasound
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Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.
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Two hours after endobronchial ultrasound
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physician's assessment of patient comfort
時間枠：Immediately after the procedure (within 10 minutes)
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Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.
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Immediately after the procedure (within 10 minutes)
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Duration of endobronchial ultrasound procedure
時間枠：During the procedure
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Measured in minutes.
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During the procedure
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Total doses of sedation
時間枠：Immediately after the procedure (within 10 minutes)
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Total doses of each sedative used will be recorded.
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Immediately after the procedure (within 10 minutes)
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Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia
時間枠：During the procedure and up to two hours after
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During the procedure and up to two hours after
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Proportion of adequate cytology specimens in each group
時間枠：Days after the procedure (results usually available within 10 days)
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Days after the procedure (results usually available within 10 days)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Stéphane Beaudoin, MD、Laval University
- 主任研究者：Simon Martel, MD、Laval University
- 主任研究者：Antoine Delage, MD、Laval University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
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。