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

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Conditions studied: Extubation Failures, Extubation, Airway Complication of Anaesthesia

In brief

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.

Key facts

Study ID

NCT07752173

Run by

Kocaeli City Hospital

People needed

2640

Starts

2026-08-03

Expected to finish

2027-05-15

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Kocaeli City Hospital — Kocaeli, Izmıt, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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