Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours: A Prospective Observational Cohort Study
調査の概要
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Mehmet Yilmaz, Md
- 電話番号:05052174432
- メール:drmyilmaz33@gmail.com
研究連絡先のバックアップ
- 名前:Ali Mete Temel, Md
- 電話番号:+905438465215
- メール:metetemel60@hotmail.com
研究場所
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Izmıt
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Kocaeli、Izmıt、トルコ(Türkiye)、41001
- 募集
- Kocaeli City Hospital
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コンタクト:
- Mehmet Yilmaz, Md
- 電話番号:05052174432
- メール:drmyilmaz33@gmail.com
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副調査官:
- Mehmet Yilmaz, Md
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コンタクト:
- Ali Mete Temel, Md
- 電話番号:+905438465215
- メール:metetemel60@hotmail.com
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主任研究者:
- Ali Mete Temel, Md
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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:
- Age ≥ 18 years
Undergoing elective or emergency surgery under general anaesthesia with endotracheal intubation
Planned tracheal extubation in the operating theatre or post-anaesthesia care unit (PACU)
Provision of written informed consent (or deferred consent for emergency cases, in accordance with national regulations)
Exclusion Criteria:
- Patients undergoing surgery under regional anaesthesia or sedation without endotracheal intubation
Patients with a tracheostomy in situ
Patients who remain intubated and are transferred to the intensive care unit (ICU) postoperatively
Patients undergoing cardiothoracic surgery involving cardiopulmonary bypass
Emergency airway management performed outside the operating theatre (e.g., ICU, emergency department)
Patients with known or suspected difficult airway requiring awake fibreoptic intubation
Patients who refuse to provide informed consent or withdraw consent during the study
Pregnant patients
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 |
介入・治療 |
|---|---|
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On-Hours
On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays.
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An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.
Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure.
This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation.
The KSS score will be recorded as a predictor/exposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation.
This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).
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Off-Hours
Off-hours group: Extubations performed after 16:00 on weekdays, as well as all extubations performed on weekends and public holidays, regardless of the time of day
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An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.
Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure.
This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation.
The KSS score will be recorded as a predictor/exposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation.
This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).
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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 Desaturation During Extubation
時間枠:30 min. after extubation
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Description: The occurrence of desaturation during the extubation procedure itself, defined as a peripheral oxygen saturation (SpO₂) < 90% lasting for ≥ 30 seconds (or a ≥ 5% decrease from baseline in patients with pre-existing hypoxaemia), measured from the initiation of extubation manoeuvres (cuff deflation and suctioning) until the complete withdrawal of the endotracheal tube. Time Frame: Desaturation occurring during the extubation attempt and within the first 30 minutes post-extubation. |
30 min. after extubation
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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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Other acute airway/respiratory complications
時間枠:30 min. after extubation
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(laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway).
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30 min. after extubation
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intervention requirement by type
時間枠:30 min. after extubation
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(simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway)
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30 min. after extubation
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Mehmet Yilmaz、Kocaeli City Hospital
出版物と役立つリンク
一般刊行物
- Xie Q, Shen Z, Pan M, Li Y, Luo Z, Wang C, Zhao L, Fang Y, Ding X, Teng J, Xu J. Weekend effect on the incidence and outcomes of cardiac surgery associated - acute kidney injury. BMC Cardiovasc Disord. 2023 Oct 27;23(1):524. doi: 10.1186/s12872-023-03431-4.
- Patel MS, Thomas JJ, Aguayo X, Gutmann D, Sarwary SH, Wain M. The Effect of Weekend Surgery on Outcomes of Emergency Laparotomy: Experience at a High Volume District General Hospital. Cureus. 2022 Mar 27;14(3):e23537. doi: 10.7759/cureus.23537. eCollection 2022 Mar.
- Ash-Rafzadeh H, Chambers TJ, Velez FO, Moodie CC, Garrett JR, Fontaine JP, Toloza EM. Effect of Surgical Day of Week on Postoperative Outcomes After Robotic-Assisted Pulmonary Lobectomy. Cureus. 2023 Feb 23;15(2):e35379. doi: 10.7759/cureus.35379. eCollection 2023 Feb.
- Maman D, Steinfeld Y, Berkovich Y. No Weekend Effect in Elective Primary Total Knee Arthroplasty: A Nationwide Analysis of 437,121 U.S. Cases. J Clin Med. 2025 Dec 12;14(24):8816. doi: 10.3390/jcm14248816.
- Cortegiani A, Gregoretti C, Neto AS, Hemmes SNT, Ball L, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Melo MFV, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS Investigators, the PROVE Network, and the Clinical Trial Network of the European Society of Anaesthesiology. Association between night-time surgery and occurrence of intraoperative adverse events and postoperative pulmonary complications. Br J Anaesth. 2019 Mar;122(3):361-369. doi: 10.1016/j.bja.2018.10.063. Epub 2019 Feb 8.
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KSH-2026-89
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?
IPD プランの説明
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
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