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临床试验/NCT07146984
NCT07146984Enrolling By Invitation不适用

Application of PDCA Cycle in Tracheal Intubation Training for Emergency Medicine Residents

Guangzhou Panyu Central Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
First-Attempt Success Rate of Tracheal Intubation

研究概览

简要总结

Tracheal intubation is a critical but technically demanding procedure in emergency airway management. Junior emergency medicine residents often struggle to achieve proficiency, leading to increased risks of complications. This study evaluates the effectiveness of a Plan-Do-Check-Act (PDCA) cycle-based training program in improving intubation skills.

The study was conducted in the emergency department of a tertiary teaching hospital. Residents performing intubations in 2023 with conventional training served as the control group, while those trained with the PDCA model in 2024 formed the intervention group. The PDCA program included structured lectures, high-fidelity simulation, supervised clinical practice, and iterative feedback.

Primary outcomes were first-attempt success rate and intubation completion time. Secondary outcomes included incidence of local airway trauma, extubation failure due to airway injury within 72 hours, and resident satisfaction. This study aims to provide evidence that PDCA-based training can enhance procedural competency, safety, and learner satisfaction in emergency airway management.

详细描述

Tracheal intubation is a high-risk, time-sensitive procedure that is fundamental to emergency airway management. Despite its lifesaving role, it remains one of the most technically challenging skills for junior emergency medicine residents. Failed or delayed intubation is associated with serious complications, including airway trauma, hypoxemia, aspiration, and cardiac arrest. Traditional didactic training often lacks the iterative practice and structured feedback required for durable skill acquisition.

The Plan-Do-Check-Act (PDCA) cycle is an educational quality improvement framework that emphasizes continuous evaluation, feedback, and refinement. This study was designed to investigate whether a PDCA-based training model could improve intubation competency among emergency medicine residents in a tertiary teaching hospital.

This prospective observational study compared intubation performance before and after PDCA cycle implementation. The control group included residents performing intubations in 2023 with conventional training, while the intervention group included residents trained with the PDCA model in 2024. The PDCA program consisted of structured didactic sessions, high-fidelity simulation, supervised clinical practice, and iterative debriefing with continuous feedback loops.

Primary outcomes were first-attempt success rate and intubation completion time, as these are widely recognized benchmarks of procedural safety and efficiency. Secondary outcomes included the incidence of local airway trauma, extubation failure due to airway injury within 72 hours, and resident satisfaction with training.

We hypothesized that PDCA-based training would significantly improve first-pass success, shorten intubation time, reduce airway-related complications, and enhance trainee satisfaction. The findings may provide evidence for adopting structured, feedback-oriented frameworks in emergency and critical care training, with broader implications for competency-based medical education.

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
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Emergency medicine residents rotating in the emergency department during the study period.
  • Residents who are required to perform tracheal intubation as part of clinical training.
  • Residents who have completed baseline theoretical and simulation-based airway management training.
  • Voluntary participation with written informed consent.

排除标准

  • • Residents who refuse to participate or withdraw consent.
  • Residents with prior advanced airway fellowship training or extensive intubation experience (>50 independent intubations).
  • Residents who are unable to complete the full PDCA-based training program due to absence or rotation schedule.
  • Any medical condition or circumstance deemed by investigators to interfere with participation or data integrity.

结局指标

主要结局

First-Attempt Success Rate of Tracheal Intubation

时间窗: Within procedure (immediately at time of intubation)

The proportion of tracheal intubation attempts by emergency medicine residents successfully completed on the first attempt, as verified by standard clinical confirmation (e.g., chest rise, end-tidal CO₂, auscultation, chest X-ray).

次要结局

  • Intubation Completion Time(Periprocedural (measured once during each intubation attempt, from laryngoscope insertion to confirmed tracheal tube placement, using a stopwatch)
  • Incidence of Local Airway Trauma(Assessment was performed immediately after completion of intubation and within 5 minutes post-procedure, by direct laryngoscopic visualization or suction catheter inspection)
  • Extubation Failure Due to Airway Injury(Assessment was performed within 72 hours following planned extubation. Patients were monitored for the need of reintubation, and airway injury was confirmed by laryngoscopy when extubation failure occurred.)
  • Mean Questionnaire Score on Learning Experience and Perceived Training Value(Immediately after completion of the training session (within 24 hours).)

研究者

发起方
Guangzhou Panyu Central Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Xiaowei

Associate Chief Physician

Guangzhou Panyu Central Hospital

研究点 (1)

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