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Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours

2026년 8월 15일 업데이트: Ali Mete Temel, Kocaeli City Hospital

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

2640

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Izmıt
      • Kocaeli, Izmıt, 터키 (Türkiye), 41001
        • 모병
        • Kocaeli City Hospital
        • 연락하다:
        • 부수사관:
          • Mehmet Yilmaz, Md
        • 연락하다:
        • 수석 연구원:
          • Ali Mete Temel, Md

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Desaturation During Extubation
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Other acute airway/respiratory complications
기간: 30 min. after extubation
(laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway).
30 min. after extubation

기타 결과 측정

결과 측정
측정값 설명
기간
Intervention requirement by type
기간: 30 min. after extubation
(simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway)
30 min. after extubation

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 의자: Mehmet Yilmaz, Kocaeli City Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 3일

기본 완료 (추정된)

2027년 5월 3일

연구 완료 (추정된)

2027년 5월 15일

연구 등록 날짜

최초 제출

2026년 8월 3일

QC 기준을 충족하는 최초 제출

2026년 8월 3일

처음 게시됨 (실제)

2026년 8월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 15일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • KSH-2026-89

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Study data are the exclusive property of Kocaeli City Hospital and may only be shared with formal institutional authorization.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .