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

NCT07823179 | Not Yet Recruiting

• 1 other identifier: 2026-111
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Airway Management; Intubation Complications; General Anesthesia; Tracheal Intubation

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  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

  Immediately before the intubation attempt.

Study Arms (2)

In-hours (Group M)

Patients undergoing tracheal intubation for general anesthesia during the in-hours shift (08:00-16:00).

Procedure: Tracheal Intubation

Off-hours (Group D)

Patients undergoing tracheal intubation for general anesthesia during the off-hours shift (16:01-07:59), including evenings, nights, weekends, and holidays.

Procedure: Tracheal Intubation

Interventions

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).

In-hours (Group M); Off-hours (Group D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing surgery under general anesthesia at Kocaeli City Hospital, Department of Anesthesiology and Reanimation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Merve Yazici Kara: lead

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Central Study Contacts

Merve Yazici Kara, M.D.

CONTACT

+90 533 686 01 56; merreset@hotmail.com

Mehmet Yilmaz, M.D.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share