Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients
Comparison Of Safety And Clinical Outcomes Of Sedated And Unsedated Percutaneous Endoscopic Gastrostomy Procedures İn ASA IV Elderly Patients: A Prospective Observational Cohort Study.
調査の概要
状態
詳細な説明
Percutaneous endoscopic gastrostomy is commonly used to provide long-term enteral nutrition in patients who are unable to maintain adequate oral intake. Elderly patients with severe systemic disease and high anesthetic risk may be vulnerable to sedation-related cardiopulmonary adverse events. In some clinical settings, PEG can be performed using topical pharyngeal anesthesia and local anesthesia without systemic sedation.
This study will prospectively include elderly ASA IV patients undergoing PEG placement in routine clinical practice. Patients will be categorized into two cohorts according to the sedation strategy used during the procedure: unsedated PEG and sedated PEG. The sedation strategy will not be assigned by the investigators and will be determined according to routine clinical assessment, patient condition, and anesthesiology evaluation when required.
The study will compare cardiopulmonary complications within 24 hours, technical success, procedure-related complications, and 30-day clinical outcomes between the two cohorts.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Mahsum Barçın, MD
- 電話番号：+9005448895064
- メール：dr.mahsumbarcin@gmail.com
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients with indications for percutaneous endoscopic gastrostomy for long-term enteral nutrition.
- Patients who have provided written informed consent from the patient or their legally authorized representative.
- Those with an Anesthesia Score of ASA 4.
Exclusion Criteria:
- Need for emergency PEG placement;
- International normalized ratio (INR) greater than 1.5;
- Platelet count less than 50,000/mm³;
- Severe ascites,
- Active peritonitis; pregnancy;
- Refusal to participate in the study.
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
コホートと介入
グループ/コホート |
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Unsedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy with topical pharyngeal anesthesia and local anesthesia, without systemic sedative medication.
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Sedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy under sedation as part of routine clinical practice.
Sedative agents may include propofol, midazolam, and/or opioid agents according to clinical and anesthesiology evaluation.
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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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Incidence of cardiopulmonary complications within 24 hours after PEG placement
時間枠：Within 24 hours after PEG placement
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Cardiopulmonary complications will be assessed as a composite outcome including the occurrence of at least one of the following events within the first 24 hours after PEG placement: hypoxemia defined as SpO₂ <90%, hypotension defined as mean arterial pressure <65 mmHg, bradycardia defined as heart rate <50 beats/min, aspiration, need for endotracheal intubation, or intensive care unit admission/transfer.
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Within 24 hours after PEG placement
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Hilmi Bozkurt, MD,PhD、Mersin University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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。