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临床试验/NCT07752173
NCT07752173招募中不适用

Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours: A Prospective Observational Cohort Study

Kocaeli City Hospital1 个研究点 分布在 1 个国家目标入组 2,640 人开始时间: 2026年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,640
试验地点
1
主要终点
Incidence of Desaturation During Extubation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- 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)

排除标准

  • •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

研究组 & 干预措施

On-Hours

On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays.

干预措施: Extubation (Procedure)

On-Hours

On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays.

干预措施: Survey/Questionnaire Administration (Other)

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

干预措施: Extubation (Procedure)

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

干预措施: Survey/Questionnaire Administration (Other)

结局指标

主要结局

Incidence of Desaturation During Extubation

时间窗: 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.

次要结局

  • Other acute airway/respiratory complications(30 min. after extubation)

研究者

发起方
Kocaeli City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ali Mete Temel

Anesthesiology and Reanimation Resident Physician

Kocaeli City Hospital

研究点 (1)

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