Educational ProblemsNCT05511142
Intubation and Ventilation Skill Training Using Modified Peyton's Four-Step Approach
A study testing Classic Peyton's Four-Step Approach and Modified Peyton's Four-Step Approach in people with Educational Problems, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Endotracheal intubation and mask ventilation procedural skills are basic skills which have to be learnt by medical student and have to be practiced directly. However, during COVID-19 pandemic, offline training was difficult to be conducted and new specific learning method has not established yet. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Classic Peyton's Four-Step Approach and Modified Peyton's Four-Step Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preclinical students of Faculty of Medicine Universitas Indonesia agreed to participate and signed the consent
- Preclinical students of Faculty of Medicine Universitas Indonesia registered to attend every training session of endotracheal intubation and mask ventilation under Basic Clinical Skills module
- 100% attendance in every session
Who cannot join
- Students who have attended endotracheal intubation and mask ventilation training beforehand
- Students who have learnt endotracheal intubation and mask ventilation under Basic Clinical Skills module beforehand
- Drop out Criteria:
- Preclinical students of Faculty of Medicine Universitas Indonesia who quit from Basic Clinical Skills module during research
- Students who have never attended the training session
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Effectiveness of Endotracheal Intubation and Mask Ventilation Procedural Skills Training on Preclinical Student Using Modified Peyton's Four-Step Approach During COVID-19 Pandemic
Endotracheal intubation and mask ventilation procedural skills are basic skills which have to be learnt by medical student and have to be practiced directly. However, during COVID-19 pandemic, offline training was difficult to be conducted and new specific learning method has not established yet. The study aims to assess the effectiveness of modified Peyton's four-step approach, which can be implemented through online training, compared to the classic Peyton's four-step approach in learning endotracheal intubation and mask ventilation procedural skills.
- Conditions
- Educational Problems
- Being tested
- Classic Peyton's Four-Step Approach, Modified Peyton's Four-Step Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic Peyton's Four-Step ApproachOther
Instructor demonstrated endotracheal intubation and mask ventilation procedural skills directly to the preclinical students, followed by direct hands-on practice using manequin, ended with giving feedback to the students
Modified Peyton's Four-Step ApproachOther
Video tutorial of endotracheal intubation and mask ventilation were given to the students without explanation, followed by video tutorial making using manequin (without instructor) by the students which will be uploaded to Youtube
| Study group | Role | What they receive |
|---|---|---|
| Classic Peyton's Four-Step Approach | Experimental | Students followed offline training session of endotracheal intubation and mask ventilation procedural skills Receives: Other: Classic Peyton's Four-Step Approach |
| Modified Peyton's Four-Step Approach | Experimental | Students followed online training session of endotracheal intubation and mask ventilation procedural skills Receives: Other: Modified Peyton's Four-Step Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global rating
numeric score
Measured: by the end of Basic Clinical Skill module, approximately 1-3 months after training
Actual mark
numeric score
Measured: by the end of Basic Clinical Skill module, approximately 1-3 months after training
Secondary outcomes (1)
Satisfaction score
using Likert scale
Measured: by the end of Basic Clinical Skill module, approximately 1-3 months after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldy Heriwardito, Universitas Indonesia
- Investigators
- Aldy Heriwardito, Doctor, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511142
- Sponsor's protocol ID
- IndonesiaUAnes396
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Endotracheal Intubation and Mask Ventilation Procedural Skills Training on Preclinical Student Using Modified Peyton's Four-Step Approach During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05511142
- Acronym / sponsor ID
- IndonesiaUAnes396
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Aug 2022 (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.
Endotracheal intubation and mask ventilation procedural skills are basic skills which have to be learnt by medical student and have to be practiced directly. However, during COVID-19 pandemic, offline training was difficult to be conducted and new specific learning method has not established yet. The study aims to assess the effectiveness of modified Peyton's four-step approach, which can be implemented through online training, compared to the classic Peyton's four-step approach in learning endotracheal intubation and mask ventilation procedural skills.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic Peyton's Four-Step Approach | Experimental | Other: Classic Peyton's Four-Step ApproachStudents followed offline training session of endotracheal intubation and mask ventilation procedural skills |
| Modified Peyton's Four-Step Approach | Experimental | Other: Modified Peyton's Four-Step ApproachStudents followed online training session of endotracheal intubation and mask ventilation procedural skills |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preclinical students of Faculty of Medicine Universitas Indonesia agreed to participate and signed the consent
- Preclinical students of Faculty of Medicine Universitas Indonesia registered to attend every training session of endotracheal intubation and mask ventilation under Basic Clinical Skills module
- 100% attendance in every session
Key exclusion criteria (5 listed)
- Students who have attended endotracheal intubation and mask ventilation training beforehand
- Students who have learnt endotracheal intubation and mask ventilation under Basic Clinical Skills module beforehand
- Preclinical students of Faculty of Medicine Universitas Indonesia who quit from Basic Clinical Skills module during research
- Students who have never attended the training session
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 |
|---|---|---|
| Classic Peyton's Four-Step ApproachInstructor demonstrated endotracheal intubation and mask ventilation procedural skills directly to the preclinical students, followed by direct hands-on practice using manequin, ended with giving feedback to the students | Other | Classic Peyton's Four-Step Approach |
| Modified Peyton's Four-Step ApproachVideo tutorial of endotracheal intubation and mask ventilation were given to the students without explanation, followed by video tutorial making using manequin (without instructor) by the students which will be uploaded to Youtube | Other | Modified Peyton's Four-Step Approach |
Primary outcome
Global rating
Time frame: by the end of Basic Clinical Skill module, approximately 1-3 months after training
numeric score
Actual mark
Time frame: by the end of Basic Clinical Skill module, approximately 1-3 months after training
numeric score
1 secondary outcome
Satisfaction score
Time frame: by the end of Basic Clinical Skill module, approximately 1-3 months after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Aldy Heriwardito, Doctor principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic Peyton's Four-Step Approach and Modified Peyton's Four-Step Approach in people with Educational Problems, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 2022. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global rating (time frame: by the end of Basic Clinical Skill module, approximately 1-3 months after training). The study lists 2 primary outcomes in all. 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 Aug 2022.