NCT07146984

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

August 16, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

PDCA cycleemergency medicinetracheal intubationmedical education

Outcome Measures

Primary Outcomes (1)

  • First-Attempt Success Rate of Tracheal 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).

    Within procedure (immediately at time of intubation)

Secondary Outcomes (4)

  • 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).

Study Arms (1)

PDCA Cycle-Based Training Intervention

The Plan-Do-Check-Act (PDCA) cycle Based Training Intervention

Behavioral: Behavioral (Educational Training Program)

Interventions

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.

PDCA Cycle-Based Training Intervention

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Emergency medicine residents from the Department of Emergency, Panyu Central Hospital, Guangzhou Medical University, China. Participants were postgraduate residents rotating in the emergency department during the study period and were required to perform tracheal intubation as part of their clinical training.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 511000, China

Location

Study Officials

  • yingshen wen

    Department of emergency, The Affiliated Panyu Central Hospital, Guangzhou Medical University, China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 28, 2025

Study Start

October 1, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations