Tracheal IntubationPACTNCT07146984
Application of PDCA Cycle in Tracheal Intubation Training for Emergency Medicine Residents
An observational study of Tracheal Intubation and Medical Education, run by Guangzhou Panyu Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Tracheal Intubation, Medical Education
- What is being tested?
- Behavioral (Educational Training Program)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Sep 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 511000
About this study
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.
Read the detailed description
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.
- Conditions
- Tracheal Intubation, Medical Education
- Being tested
- Behavioral (Educational Training Program)
- Keywords
- PDCA cycle, emergency medicine, tracheal intubation, medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral (Educational Training Program)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PDCA Cycle-Based Training Intervention | The Plan-Do-Check-Act (PDCA) cycle Based Training Intervention Receives: Behavioral: Behavioral (Educational Training Program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within procedure (immediately at time of intubation)
Secondary outcomes (4)
Intubation Completion Time
Time in seconds from insertion of the laryngoscope to confirmation of successful tube placement.
Measured: Periprocedural (measured once during each intubation attempt, from laryngoscope insertion to confirmed tracheal tube placement, using a stopwatch
Incidence of Local Airway Trauma
Presence of fresh blood in the airway post-intubation, excluding bleeding from preexisting conditions (e.g, subglottic mass, pulmonary hemorrhage).
Measured: 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
Reintubation within 72 h despite meeting extubation criteria, confirmed by laryngoscopy (e.g., edema, vocal cord paralysis, granulation, or subglottic stenosis).
Measured: 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
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.
Measured: Immediately after completion of the training session (within 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Oct 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Guangzhou Panyu Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Xiaowei, Guangzhou Panyu Central Hospital
- Investigators
- yingshen wen, Study director, Department of emergency, The Affiliated Panyu Central Hospital, Guangzhou Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146984
- Sponsor's protocol ID
- PYRC-2024-280-01
- Acronym
- PACT
- Status last verified
- Sep 2025
- First submitted
- 16 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of PDCA Cycle in Tracheal Intubation Training for Emergency Medicine Residents
- ClinicalTrials.gov ID
- NCT07146984
- Acronym / sponsor ID
- PACT / PYRC-2024-280-01
- Conditions
- Tracheal Intubation, Medical Education
- Keywords
- PDCA cycle, emergency medicine, tracheal intubation, medical education
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Panyu Central HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDCA Cycle-Based Training Intervention | – | Behavioral: Behavioral (Educational Training Program)The Plan-Do-Check-Act (PDCA) cycle Based Training Intervention |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- • Residents who refuse to participate or withdraw consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral (Educational Training Program)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. | Behavioural | PDCA Cycle-Based Training Intervention |
Primary outcome
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).
4 secondary outcomes
Intubation Completion Time
Time frame: Periprocedural (measured once during each intubation attempt, from laryngoscope insertion to confirmed tracheal tube placement, using a stopwatch
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
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.
Mean Questionnaire Score on Learning Experience and Perceived Training Value
Time frame: Immediately after completion of the training session (within 24 hours).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yingshen wen study director
Department of emergency, The Affiliated Panyu Central Hospital, Guangzhou Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Intubation and Medical Education, run by Guangzhou Panyu Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Attempt Success Rate of Tracheal Intubation (time frame: Within procedure (immediately at time of intubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.