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临床试验/NCT07823179
NCT07823179尚未招募不适用

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

Merve Yazici Kara0 个研究点目标入组 1,000 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
Incidence of Tracheal Intubation-Related Complications

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

In-hours (Group M)

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

干预措施: Tracheal Intubation (Procedure)

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.

干预措施: Tracheal Intubation (Procedure)

结局指标

主要结局

Incidence of Tracheal Intubation-Related Complications

时间窗: 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.

Tracheal Intubation Duration

时间窗: 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.

次要结局

  • Pre-Intubation Sleepiness Level of the Performing Anesthesiologist(Immediately before the intubation attempt.)

研究者

发起方
Merve Yazici Kara
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Merve Yazici Kara

Assistant Professor of Anesthesiology and Reanimation

Kocaeli City Hospital

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