Effect of Working Hours and Night Shifts on Airway Management in Surgical Patients: A Prospective Cohort Analysis of Tracheal Intubation Complications and Duration
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
- 否
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
Merve Yazici Kara
Assistant Professor of Anesthesiology and Reanimation
Kocaeli City Hospital
