About this trial
Airway management is one of the most critical steps of anesthesia, and its complications can be life-threatening. Reduced staffing, differences in personnel experience, and physical and mental fatigue during off-hours (evenings, nights, weekends, and holidays) may affect the quality of care and patient safety - a phenomenon described in the literature as the "after-hours effect." While this effect has been studied for outcomes such as cardiac arrest and intensive care mortality, evidence specific to airway management safety remains limited. This prospective observational cohort study aims to evaluate the effect of shift timing on the safety and efficiency of tracheal intubation in adult surgical patients undergoing general anesthesia at a single center. Based on the actual start time of anesthesia, patients will be categorized into an in-hours group (08:00-16:00) or an off-hours group (16:01-07:59), without any investigator-assigned intervention. The frequency and type of intubation-related complications, intubation duration, and the pre-intubation sleepiness level of the performing anesthesiologist (assessed using the Karolinska Sleepiness Scale) will be compared between groups. The investigators hypothesize that intubations performed during off-hours are associated with a higher complication rate and longer intubation duration than those performed during in-hours. Approximately 1000 patients will be enrolled over a period of up to 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years of age
undergoing surgery under general anesthesia
ASA physical status I, II, or III
Disqualifiers
Patients arriving to the operating room already intubated
Patients who do not provide written or verbal consent
Trial population
Adult patients undergoing surgery under general anesthesia at Kocaeli City Hospital, Department of Anesthesiology and Reanimation.
Trial design
Cohort
Prospective
Treatments tested in this trial
Tracheal Intubation
Procedure/SurgeryStandard tracheal intubation performed as part of routine general anesthesia care. The procedure itself is not assigned or altered by the investigators; all patients receive the same standard clinical care, and groups differ only in the timing of the procedure (in-hours vs. off-hours).
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Tracheal Intubation-Related Complications
Frequency and type of intubation-related complications (e.g., difficult intubation, multiple attempts, desaturation, esophageal intubation) compared between the in-hours and off-hours groups.
Tracheal Intubation Duration
Time elapsed from the first attempt to insert the airway device to the first capnographic waveform confirming successful tracheal intubation, measured in seconds.
Secondary outcomes
Pre-Intubation Sleepiness Level of the Performing Anesthesiologist
Subjective sleepiness level of the physician performing the intubation, assessed immediately before the procedure using the Karolinska Sleepiness Scale (KSS, 1-9), to explore the association between fatigue and shift-related differences in intubation outcomes.
Locations
Sponsors and contacts
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Merve Yazici Kara
Lead sponsor
Kocaeli City Hospital
Sponsor institution
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