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

lauantai 15. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

2640

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

    • Izmıt
      • Kocaeli, Izmıt, Turkki (Türkiye), 41001
        • Rekrytointi
        • Kocaeli City Hospital
        • Ottaa yhteyttä:
        • Alatutkija:
          • Mehmet Yilmaz, Md
        • Ottaa yhteyttä:
        • Päätutkija:
          • Ali Mete Temel, Md

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
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).

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Incidence of Desaturation During Extubation
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Other acute airway/respiratory complications
Aikaikkuna: 30 min. after extubation
(laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway).
30 min. after extubation

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Intervention requirement by type
Aikaikkuna: 30 min. after extubation
(simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway)
30 min. after extubation

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Tutkijat

  • Opintojen puheenjohtaja: Mehmet Yilmaz, Kocaeli City Hospital

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Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

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IPD-suunnitelman kuvaus

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

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