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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Interventions: Extubation (Procedure), Survey/Questionnaire Administration (Other) to Extubation (Procedure), Survey/Questionnaire Administration (Other)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: details revised at 5 of 5 entries
    • Eligibility criteria expanded, about 1 word
  2. Recruitment opened
    • Site details revised
    v3
  3. Study title shortened, about 5 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07752173
Lead Sponsor Kocaeli City Hospital
Conditions
(from sponsor)		 Extubation Failures, Extubation, Airway Complication of Anaesthesia
Enrollment 2,640 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov