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NCT Number: NCT07823179

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years of age
  • undergoing surgery under general anesthesia
  • ASA physical status I, II, or III

Exclusion criteria

  • Patients arriving to the operating room already intubated
  • Patients who do not provide written or verbal consent

Treatment and study plan

tracheal intubation

Procedure

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).

Primary outcomes

  1. Incidence of Tracheal Intubation-Related Complications

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

    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.

  2. Tracheal Intubation Duration

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

    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

  1. Pre-Intubation Sleepiness Level of the Performing Anesthesiologist

    Time frame: Immediately before the intubation attempt.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Yilmaz, M.D.

CONTACT

Merve Yazici Kara, M.D.

CONTACT

[email protected]

+90 533 686 01 56

Sponsors and collaborators

Lead sponsor

Merve Yazici Kara

Other Gov

Registry information

Official study title

Effect of Working Hours and Night Shifts on Airway Management in Surgical Patients: A Prospective Cohort Analysis of Tracheal Intubation Complications and Duration

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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