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

Recruitingn/aAges 18 Years - anyAllKocaeli City Hospital
NCT07752173 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-

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📋 Eligibility rules (as published)
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
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What it tests

  • Extubation
  • Survey/Questionnaire Administration
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Where

1 site
Kocaeli City Hospital
Kocaeli, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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