Sedation vs No Sedation in Mechanically Ventilated COPD Patients (SEDvsNO-COPD)
Compareson Between Sedation and No Sedation in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
調査の概要
詳細な説明
Mechanical ventilation is a stressful experience for critically ill patients, often associated with pain, discomfort, and anxiety due to invasive procedures, environmental factors, and underlying disease. Sedation is commonly used in intensive care units to improve patient comfort and tolerance to mechanical ventilation. However, excessive sedation has been associated with prolonged mechanical ventilation, longer ICU stay, and increased complications.
Daily interruption of sedation (DIS) has been introduced to reduce sedation-related complications and improve outcomes. Recent trends support minimizing sedation and promoting patient comfort using alternative approaches. However, the optimal sedation strategy in patients with chronic obstructive pulmonary disease (COPD) remains unclear, especially in those with hypercapnic respiratory failure, where sedative drugs may worsen respiratory depression.
This study is a prospective randomized controlled trial conducted in the respiratory intensive care unit at Al-Azhar University Hospital, Assiut, Egypt 100 adult patients with COPD exacerbation requiring invasive mechanical ventilation will be enrolled and randomly assigned into two groups:
Group A (control group): Patients will receive sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).
Group B (intervention group): Patients will be managed with a no-sedation protocol. Sedation will only be administered if clinically indicated due to agitation or discomfort.
All patients will receive standard medical treatment for COPD and will be monitored clinically and by laboratory and radiological investigations. Weaning from mechanical ventilation will be performed according to standard criteria.
The primary outcome is ventilator-free days. Secondary outcomes include ICU length of stay, incidence of complications, difficulty of weaning, and nursing workload.
Ethical approval has been obtained, and informed consent will be secured from patients or their legal representatives before enrollment.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Asyut、エジプト
- Al-Azhar University Hospital, Assiut
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Adult patients (≥18 years old). Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring invasive mechanical ventilation.
Previously diagnosed COPD confirmed by post-bronchodilator FEV1/FVC < 70%. Patients admitted to the respiratory intensive care unit (ICU).
Exclusion Criteria:
Known allergy to midazolam. Renal impairment. Hepatic impairment. Active malignancy (cancer). Psychiatric disorders. Neurological disorders. Pregnancy.
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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：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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アクティブコンパレータ：Daily Interruption of Sedation (DIS)
Patients will receive continuous sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).
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Midazolam will be given as needed in bolus doses if agitation occurs.
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実験的：No Sedation Protocol
Patients will be managed without continuous sedation.Sedation will be administered only if clinically indicated due to agitation or discomfort.
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Midazolam will be given as needed in bolus doses if agitation occurs.
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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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Ventilator-free days during the first 28 days after initiation of mechanical ventilation
時間枠：28 days after enrollment
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Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment.
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28 days after enrollment
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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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Incidence of complications during ICU stay
時間枠：During ICU stay, assessed daily up to 28 days
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Occurrence of complications including ventilator-associated pneumonia, hemodynamic instability, or need for reintubation during ICU stay.
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During ICU stay, assessed daily up to 28 days
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Length of ICU stay
時間枠：From ICU admission to ICU discharge, up to 28 days
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Duration of stay in the intensive care unit measured in days from ICU admission until discharge.
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From ICU admission to ICU discharge, up to 28 days
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Difficulty of weaning from mechanical ventilation
時間枠：From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
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Assessment of weaning difficulty based on duration of weaning process, number of spontaneous breathing trial failures, and need for prolonged mechanical ventilation.
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From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
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協力者と研究者
スポンサー
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- MSC/AZ.AST./CHT019/5/242/4/202
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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