Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients
This prospective, non-interventional observational study will evaluate the risk of reintubation in adult postoperative patients admitted to the intensive care unit after major surgery. Reintubation after extubation is an important clinical problem because it may increase complications, prolong mechanical ventilation, and extend intensive care and hospital stay.
The study will include adult patients who are extubated in the operating room and admitted to the intensive care unit with spontaneous breathing. Within the first hours after ICU admission, bedside ultrasound measurements of diaphragm thickness, parasternal intercostal muscle thickness, and lung ultrasound score will be performed. The ROX index will also be calculated using oxygen saturation, inspired oxygen concentration, and respiratory rate. Perioperative fluid balance will be recorded from anesthesia and patient files.
Patients will be followed for 48 to 72 hours after ICU admission to determine whether reintubation is required. The study aims to assess whether respiratory muscle ultrasound findings, lung ultrasound score, ROX index, and perioperative fluid balance can help predict reintubation risk in postoperative ICU patients. No additional treatment or intervention will be applied as part of the study, and all clinical decisions will be made by the responsible intensive care team according to routine clinical practice.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Şişli
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Istanbul、Şişli、トルコ(Türkiye)、34360
- 募集
- Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
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コンタクト:
- Zekeriya Ervatan
- 電話番号:+9005055983248
- メール:zek.ervatan@gmail.com
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
Adult patients aged 18 years and older
Patients requiring postoperative intensive care follow-up after major surgery, including abdominal, vascular, orthopedic, or ear, nose, throat, head and neck surgery
Patients extubated in the operating room and admitted to the intensive care unit with spontaneous breathing
Patients without any clinical condition preventing the planned measurements within the first 0-2 hours after ICU admission (T0 and T1)
Patients for whom written informed consent can be obtained from the patient or legally authorized representative
Patients admitted to the intensive care unit within the specified study period after ethics committee approval and enrolled consecutively
Exclusion Criteria:
Patients younger than 18 years of age
Patients who leave the operating room intubated or are admitted to the intensive care unit while intubated
Patients with a tracheostomy
Patients with a history of diaphragmatic paralysis
Patients with a significant neuromuscular disease, such as ALS, myasthenia gravis, or similar conditions
Patients with conditions that significantly prevent ultrasound measurements, including marked subcutaneous emphysema, large dressings or bandages covering the measurement area, inability to access the measurement site due to drains or the surgical field, or inability to obtain technically adequate images
Patients in whom the planned measurements cannot be performed due to clinical instability requiring emergency intubation immediately after ICU admission
Patients from whom informed consent cannot be obtained, or patients or legally authorized representatives who refuse 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
コホートと介入
グループ/コホート |
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Reintubation group
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No reintubation group
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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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Reintubation Within 72 Hours After Intensive Care Unit Admission
時間枠:From intensive care unit admission to 72 hours after admission
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The primary outcome is the development of reintubation within the first 72 hours after admission to the intensive care unit.
Reintubation is defined as the need for endotracheal intubation after initial extubation in the operating room and admission to the intensive care unit with spontaneous breathing.
The decision for reintubation will be made by the responsible intensive care team according to routine clinical criteria and independently of the study protocol.
The outcome will be recorded as yes or no.
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From intensive care unit admission to 72 hours after admission
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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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Diaphragm Thickness at Intensive Care Unit Admission
時間枠:Within 0-30 minutes after intensive care unit admission
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Diaphragm thickness will be measured by bedside ultrasonography within the first 0-30 minutes after intensive care unit admission.
Measurements will be obtained from the same anatomical site with at least three repeated measurements, and the mean value will be used for analysis.
Diaphragm thickness values will be evaluated for their association with reintubation within 72 hours.
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Within 0-30 minutes after intensive care unit admission
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Parasternal Intercostal Muscle Thickness at Intensive Care Unit Admission
時間枠:Within 0-30 minutes after intensive care unit admission
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Parasternal intercostal muscle thickness will be measured by bedside ultrasonography within the first 0-30 minutes after intensive care unit admission.
At least three repeated measurements will be obtained, and the mean value will be used for analysis.
Parasternal intercostal muscle thickness values will be evaluated for their association with reintubation within 72 hours.
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Within 0-30 minutes after intensive care unit admission
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Lung Ultrasound Score at Intensive Care Unit Admission
時間枠:Within 0-30 minutes after intensive care unit admission
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Lung ultrasound score will be assessed using a 12-region lung ultrasound examination.
Each region will be scored from 0 to 3, and the total score will range from 0 to 36.
Higher scores indicate greater loss of lung aeration.
Lung ultrasound score will be evaluated for its association with reintubation within 72 hours.
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Within 0-30 minutes after intensive care unit admission
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Hattori J, Tanaka A, Kosaka J, Hirao O, Furushima N, Maki Y, Kabata D, Uchiyama A, Egi M, Morimatsu H, Mizobuchi S, Kotake Y, Shintani A, Koyama Y, Yoshida T, Fujino Y. Clinical predictors of extubation failure in postoperative critically ill patients: a post-hoc analysis of a multicenter prospective observational study. BMC Anesthesiol. 2025 Mar 15;25(1):127. doi: 10.1186/s12871-025-02996-1.
- Masaki H, Suzuki S, Nakayama N, Kobayashi E, Fujii A, Nishiwaki K, Mizuno M, Nakatochi M. Risk markers for postoperative reintubation of intensive care unit patients: A retrospective multicentre study of the National Intensive Care Registry. Intensive Crit Care Nurs. 2025 Apr;87:103956. doi: 10.1016/j.iccn.2025.103956. Epub 2025 Feb 3.
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
その他の研究ID番号
- 312923028
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