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
- Extubation Failures
- Extubation
- Airway Complication of Anaesthesia
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Kocaeli City Hospital
- Enrolment target
- 2,640
- Started
- 3 August 2026
- Main results due
- 3 May 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Kocaeli City Hospital
Kocaeli, Izmıt, Turkey (Türkiye)
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07752173. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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