進行性気管支鏡検査手順のための先制の気管内挿管による深い鎮静
進行性気管支鏡検査手順のための先制浸透性気管内挿管を伴う手続き監督の方向下での深い鎮静の安全性と実現可能性に関する観察前向き研究
Bronchoscopy is crucial for diagnosing and treating respiratory diseases and is recommended under sedation. Deep sedation improves patient comfort and procedural efficiency, especially in complex cases, by reducing movement and coughing. However, it carries risks of respiratory depression and airway obstruction, potentially requiring premature termination or urgent intubation. Determining the optimal timing for intubation can be challenging despite proper monitoring. To enhance safety, the investigator has performed bronchoscopy under deep sedation with preemptive intubation for years, sharing this experience with other hospitals. This study aims to evaluate its safety and feasibility through a multicenter prospective observational approach.
調査の概要
状態
条件
詳細な説明
Bronchoscopy is a crucial procedure for diagnosing and treating respiratory diseases. It is recommended to be performed under sedation whenever possible, with sedation levels ranging from minimal to moderate and deep sedation. Deep sedation enhances patient comfort and facilitates the procedure, making it particularly useful for lengthy or complex bronchoscopic examinations. Additionally, deep sedation reduces involuntary patient movements and coughing, allowing the proceduralist to perform bronchoscopy more effectively when the patient is deeply sedated.
Despite its benefits, deep sedation carries the risk of respiratory depression and impaired airway maintenance, which may necessitate early termination of the bronchoscopy. If respiratory suppression or inadequate airway maintenance occurs during deep sedation, the procedure may need to be interrupted for endotracheal intubation using the bronchoscope. However, even with appropriate monitoring during bronchoscopy, determining the optimal timing for endotracheal intubation can be challenging, potentially disrupting procedural continuity and reducing the likelihood of a successful examination.
To enhance patient comfort and procedural safety, the investigator has been performing bronchoscopy under deep sedation with preemptive endotracheal intubation for several years. This clinical experience has been shared with other university hospitals in the region, and cases of deep sedation with preemptive intubation under the supervision of bronchoscopists have been reported. This study aims to evaluate the safety and feasibility of deep sedation with preemptive endotracheal intubation during bronchoscopy through a multicenter prospective observational approach.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Yangsan、韓国
- Pusan National University Yangsan Hospital
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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
Patients with pulmonary lesions
説明
Inclusion Criteria:
- Patients requiring a bronchoscopy-assisted procedure for diagnostic or therapeutic purposes
- Individuals who voluntarily consent to participate in the clinical study and sign a written informed consent form
Exclusion Criteria:
- Patients who have experienced acute myocardial infarction or acute stroke within the past six weeks
- Patients with contraindications to bronchoscopy (e.g., severe respiratory or cardiovascular comorbidities)
- Patients with a history of allergy to benzodiazepines, propofol, fentanyl, or flumazenil
- Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Patients with a severe hypersensitivity reaction to dextran 40
- Patients with a history of acute angle-closure glaucoma
- Pregnant women
- Prisoners
- Patients with psychiatric disorders
- Patients classified as ASA Physical Status IV or V by the American Society of Anesthesiologists (ASA)
- Any other patients deemed unsuitable for the clinical study by the investigator
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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診断または治療の目的で気管支鏡検査補助手順を必要とする患者
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If an eligible subject consents to participate in the study, deep sedation and preemptive endotracheal intubation will be performed, followed by bronchoscopy. Deep sedation will be administered according to the study protocol, with final approval of sedative administration given by the proceduralist. Oxygen will be supplied at a flow rate of 4-6 L/min via a nasal cannula before sedative administration. To achieve a deep sedation state (Modified Observer's Assessment of Alertness/Sedation [MOAA/S] score ≤ 2, defined as the patient not opening their eyes despite repeated verbal stimuli), an initial dose of 50 mcg fentanyl will be administered, followed by 2.5-5 mg of remimazolam. The sedation depth will be assessed every two minutes using the MOAA/S score. If the patient has not reached deep sedation, an additional 2.5 mg of remimazolam will be administered. Once deep sedation is achieved, lidocaine will be sprayed onto the trachea and bronchi using a bronchoscope for local anesthe |
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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The incidence of hypoxia during deep sedation under proceduralist guidance with endotracheal intubation
時間枠：On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
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This study investigates the incidence of hypoxia during deep sedation under the proceduralist's guidance with endotracheal intubation. Hypoxia is defined as an oxygen saturation of less than 94% sustained for more than 10 seconds during the procedure. |
On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
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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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The incidence of severe hypoxia during deep sedation under proceduralist guidance with endotracheal intubation
時間枠：On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
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This study investigates the incidence of hypoxia during deep sedation under the proceduralist's guidance with endotracheal intubation. Hypoxia is defined as an oxygen saturation of less than 90% sustained for more than 60 seconds during the procedure. |
On the day of the bronchoscopy procedure, from the initiation of sedation therapy to the completion of the bronchoscopy procedure.
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The incidence of complications
時間枠：From the day of the bronchoscopy procedure to the outpatient visit one week after the procedure.
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early termination or delay of the procedure, complications from endotracheal intubation, complications from bronchoscopy |
From the day of the bronchoscopy procedure to the outpatient visit one week after the procedure.
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The rate of patient satisfaction
時間枠：From the completion of the bronchoscopy procedure to the point when the patient has fully recovered from sedation.
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Patient satisfaction immediately after the procedure is assessed by two items: distress during fiberoptic bronchoscopy (distress/ tolerable/ no distress or satisfied) and willingness to be reexamined (accept/ never again). |
From the completion of the bronchoscopy procedure to the point when the patient has fully recovered from sedation.
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協力者と研究者
捜査官
- 主任研究者：Hee Yun Seol, MD, PhD、Pusan National University Yangsan Hospital, Yangsan, South Korea
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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。