Effect of Night Shift Versus Daytime Duty on Tracheal Intubation Complications and Duration in Surgical Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMerve Yazici Kara

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tracheal Intubation

    Procedure/Surgery

    Standard 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

1,000 Participants
are divided into 2 treatment groups
Group A: In-hours (Group M)1 intervention
Group B: Off-hours (Group D)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At the time of tracheal intubation (single procedural assessment, during the induction of anesthesia).
2

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.

Time frame
At the time of tracheal intubation (single procedural assessment, during the induction of anesthesia).

Secondary outcomes

1

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.

Time frame
Immediately before the intubation attempt.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merve Yazici Kara

Lead sponsor

Kocaeli City Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: