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
Perioperative airway/respiratory complications are a major driver of morbidity and mortality. While UK audits NAP4 and NAP7 extensively examined major critical events (e.g., cardiac arrest), prospective standardized data on acute, more frequent extubation-phase complications-such as desaturation, laryngospasm, obstruction, bronchospasm, and aspiration-remain scarce. Off-hours procedures carry additional risks related to increased workload, reduced senior supervision, and clinician fatigue, though current evidence is inconclusive and requires further human-factors research using validated tools like the Karolinska Sleepiness Scale (KSS). This prospective cohort study at Kocaeli City Hospital aims to compare the incidence of acute airway/respiratory complications and intervention requirements during extubation and the first 30 minutes post-extubation between on-hours (08:00-16:00) and off-hours (>16:00). Notably, this will be the first prospective observational study to specifically test NAP7's off-hours risk findings at the extubation stage, with the goal of strengthening patient safety and guiding institutional quality improvement.
調査の概要
詳細な説明
Perioperative airway and respiratory complications remain a leading cause of significant morbidity and mortality in anaesthetic practice, as rigorously highlighted by the Royal College of Anaesthetists and Difficult Airway Society's 4th National Audit Project (NAP4), which comprehensively mapped the epidemiology of major airway events across anaesthesia, intensive care, and emergency departments, while particularly emphasising the disproportionately severe outcomes in emergency surgeries and non-theatre settings, as well as the pivotal role of system-level and team-related factors in shaping these adverse events. Building upon this foundation, the recently published analyses from the 7th National Audit Project (NAP7) have further substantiated that airway and respiratory complications-most notably laryngospasm, failed airway management, and pulmonary aspiration-account for a considerable proportion of perioperative cardiac arrests, reaffirming the persistent vulnerability of the airway across the entire perioperative continuum. Nevertheless, despite the invaluable contributions of NAP4 and NAP7, these landmark audits are fundamentally designed as national surveillance programmes focused on catastrophic endpoints such as major airway incidents and cardiac arrest; consequently, they have not provided prospective, standardised, and granular data on the much more frequently encountered acute airway and respiratory events that occur specifically during the extubation phase-including desaturation, laryngospasm, upper airway obstruction, bronchospasm, and regurgitation/aspiration-nor on the corresponding requirement for active clinical interventions in real-time practice, which remains a conspicuous and clinically relevant knowledge gap. This gap is further compounded by the observation that even the limited number of prospective studies concentrating on the adult extubation period have reported widely variable complication spectra and employed inconsistent definitions across different institutions, underscoring the pressing need for standardised, multicentre or single-centre prospective data that can inform robust quality benchmarks and facilitate meaningful comparisons across settings. Concurrently, a growing body of literature has raised legitimate concerns regarding the heightened perioperative risk associated with off-hours and on-call working conditions, wherein the convergence of increased workload due to concurrent emergency cases, diminished availability of senior supervisory staff, and the progressive accumulation of clinician fatigue and sleep deprivation may collectively predispose to suboptimal clinical performance and adverse patient outcomes; indeed, while off-hours surgery has been associated with higher mortality relative to daytime procedures, the existing evidence remains of low certainty, and patient-specific as well as surgical characteristics do not fully account for this observed association, thereby necessitating further investigations that specifically target human and organisational factors as explanatory variables. Within this context, the objective and validated assessment of clinician fatigue becomes particularly pertinent, and the Karolinska Sleepiness Scale (KSS), which has been widely employed in anaesthesia research, verified against electroencephalographic (EEG) measurements, and previously utilised to evaluate sleepiness levels under on-call conditions, offers a practical and psychometrically sound tool to objectively quantify the impact of fatigue on airway management performance during extubation. Motivated by these converging imperatives, this prospective observational cohort study at Kocaeli City Hospital is designed to compare the incidence of acute airway and respiratory complications, along with the associated intervention requirements, at the moment of extubation and during the immediate 30-minute post-extubation period, between extubations performed during on-hours (08:00-16:00) and those conducted during off-hours (after 16:00, as well as weekends and public holidays), with the overarching aims of strengthening institutional patient safety practices, driving evidence-based process improvements, and ultimately contributing to the broader discourse on perioperative airway safety. Notably, this investigation carries a distinctive scientific value, as it will be the first prospective observational study specifically designed to test NAP7's off-hours risk hypothesis at the extubation stage, thereby directly addressing a critical evidence gap in the current anaesthesia literature and offering actionable insights that may inform future guidelines and organisational policies regarding safe extubation practices across different times of the day.
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
-
-
Izmıt
-
Kocaeli、Izmıt、トルコ(Türkiye)、41001
- 募集
- Kocaeli City Hospital
-
コンタクト:
- Mehmet Yilmaz, Md
- 電話番号:05052174432
- メール:drmyilmaz33@gmail.com
-
副調査官:
- Mehmet Yilmaz, Md
-
コンタクト:
- Ali Mete Temel, Md
- 電話番号:+905438465215
- メール:metetemel60@hotmail.com
-
主任研究者:
- Ali Mete Temel, Md
-
-
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
The study population comprises adult patients (aged ≥ 18 years, with no upper age limit) undergoing either elective or emergency surgery under general anaesthesia with endotracheal intubation at Kocaeli City Hospital, a tertiary referral centre in Turkey. Eligible participants are those in whom tracheal extubation is planned in the operating theatre or in the post-anaesthesia care unit (PACU). The population includes both American Society of Anesthesiologists (ASA) Class I-V patients, reflecting the full spectrum of surgical acuity and comorbidity burden encountered in routine clinical practice. Patients undergoing regional anaesthesia or sedation without intubation, those with a pre-existing tracheostomy, patients transferred intubated to the intensive care unit postoperatively, and those undergoing cardiothoracic surgery involving cardiopulmonary bypass are excluded. Additionally, patients requiring emergency airway management outside the operating theatre, those with a known or susp
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
- 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 |
|---|---|
|
On-Hours
On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays. |
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). |
|
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 |
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). |
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 |
|---|---|---|
|
Incidence of Desaturation During Extubation
時間枠:30 min. after extubation
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Other acute airway/respiratory complications
時間枠:30 min. after extubation
|
(laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway). |
30 min. after extubation
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intervention requirement by type
時間枠:30 min. after extubation
|
(simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway) |
30 min. after extubation
|
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 (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
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
Study data are the exclusive property of Kocaeli City Hospital and may only be shared with formal institutional authorization.
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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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