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RecruitingNCT07752173Updated Sep 29, 2026

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

An observational study in Extubation Failures, Extubation and Airway Complication of Anaesthesia, sponsored by Kocaeli City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Kocaeli City Hospital · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,640
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Extubation Failures
  • Extubation
  • Airway Complication of Anaesthesia

Keywords

  • Extubation
  • Airway complications
  • Off-hours
  • General anaesthesia
  • Prospective cohort study
03

In context

Lead sponsor

Kocaeli City Hospital is the lead sponsor of 44 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (or deferred consent for emergency cases, in accordance with national regulations)

Exclusion criteria

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 or withdraw consent during the study

Pregnant patients

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,640 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • On-Hours

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

    Procedure: Extubation · Other: Survey/Questionnaire Administration

  • 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

    Procedure: Extubation · Other: Survey/Questionnaire Administration

Interventions

  • ProcedureExtubation

    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.

  • OtherSurvey/Questionnaire Administration

    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).

06

What researchers measure

Primary outcomes

  1. Incidence of Desaturation During 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.

    Time frame: 30 min. after extubation

Secondary outcomes

  1. Other acute airway/respiratory complications

    (laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway).

    Time frame: 30 min. after extubation

Other outcomes

  1. Intervention requirement by type

    (simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway)

    Time frame: 30 min. after extubation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 37891475 ↗
  • 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. PubMed 35494929 ↗
  • 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. PubMed 36846643 ↗
  • 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. PubMed 41464718 ↗
  • 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. PubMed 30770054 ↗

Individual participant data

Plan to share: No — Study data are the exclusive property of Kocaeli City Hospital and may only be shared with formal institutional authorization.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for May 2027, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 7, 2026
StartActual
Aug 3, 2026
Primary completionEst.
May 3, 2027
CompletionEst.
May 15, 2027
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: date precision
1 update, last Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Minor edits only
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07752173
Lead sponsor
Kocaeli City Hospital
Responsible party
Ali Mete Temel (Anesthesiology and Reanimation Resident Physician, Kocaeli City Hospital) — Principal investigator
First posted
Aug 7, 2026
Start date
Aug 3, 2026
Primary completion
May 3, 2027 (estimated)
Completion
May 15, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Ali Mete Temel, MD
Contact
metetemel60@hotmail.com
+905438465215
Mehmet Yilmaz, Md
Contact
drmyilmaz33@gmail.com
05052174432
Mehmet Yilmaz
study chair · Kocaeli City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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