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Enrolling by Invitation

NCT Number: NCT07146984

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

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.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 511000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • • 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.

Treatment and study plan

Behavioral (Educational Training Program)

Behavioral

A structured training program for emergency medicine residents based on the Plan-Do-Check-Act (PDCA) cycle. The intervention includes didactic teaching, simulation-based airway management practice, supervised clinical intubation, iterative performance assessment, and feedback-driven improvement.

Primary outcomes

  1. First-Attempt Success Rate of Tracheal Intubation

    Time frame: 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).

Secondary outcomes

  1. Intubation Completion Time

    Time frame: Periprocedural (measured once during each intubation attempt, from laryngoscope insertion to confirmed tracheal tube placement, using a stopwatch

    Time in seconds from insertion of the laryngoscope to confirmation of successful tube placement.

  2. Incidence of Local Airway Trauma

    Time frame: Assessment was performed immediately after completion of intubation and within 5 minutes post-procedure, by direct laryngoscopic visualization or suction catheter inspection

    Presence of fresh blood in the airway post-intubation, excluding bleeding from preexisting conditions (e.g, subglottic mass, pulmonary hemorrhage).

  3. Extubation Failure Due to Airway Injury

    Time frame: 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.

    Reintubation within 72 h despite meeting extubation criteria, confirmed by laryngoscopy (e.g., edema, vocal cord paralysis, granulation, or subglottic stenosis).

  4. Mean Questionnaire Score on Learning Experience and Perceived Training Value

    Time frame: Immediately after completion of the training session (within 24 hours).

    Assessed via anonymous questionnaire administered immediately after training。Scores are reported on a 5-point Likert scale (1 = very poor, 5 = excellent), with higher scores indicating a better learning experience and greater perceived training value.

Sponsors and collaborators

Lead sponsor

Guangzhou Panyu Central Hospital

Other

Registry information

Acronym: PACT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2025
Registry last updated
Sep 22, 2025

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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