Educational ActivitiesNCT03071367
A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students
A study testing Clinical Simulation in people with Educational Activities, run by Fundación Santa Fe de Bogota.
Trial summary
Multiple studies have shown clinical simulation benefits over classical learning method. Research on simulation of airway management has focused on endotracheal intubation training, while research on ventilation via facemask is scant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Activities
- What is being tested?
- Clinical Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2012to 20 Jun 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Last year medical students at Universidad de los Andes
- Over 18 year old
Who cannot join
- Previous elective anesthesia rotation
- Motor deficit affecting the upper limbs
About this study
Official title: Title: A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students: a Randomized Controlled Trial
Multiple studies have shown clinical simulation benefits over classical learning method. Research on simulation of airway management has focused on endotracheal intubation training, while research on ventilation via facemask is scant. The investigators compared both learning methods regarding the acquirement of basic skills for airway management by medical students. Students in the clinical simulation group received a 3-hour training on airway management on the first day of their 28-day anesthesia rotation, while classical learning did not. On the last day of rotation, participants were evaluated based on a validated instrument of scores. Primary outcome was airway management scores. Secondary outcomes were rate of success of intubation and incidence of complications.
- Conditions
- Educational Activities
- Being tested
- Clinical Simulation
- Keywords
- Airway Management, Medical students, Intratracheal intubation, Educational Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical SimulationOther
| Study group | Role | What they receive |
|---|---|---|
| Clinical Simulation | Experimental | Not described Receives: Other: Clinical Simulation |
| Classical Learning | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway management score
Measured: 28 days
Secondary outcomes (2)
Successful intubation rate
Measured: 28 days
Incidence of complications
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start20 Aug 2012
- Primary completion20 Feb 2014
- Study completion20 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ActivitiesStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leopoldo Ferrer, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071367
- Sponsor's protocol ID
- CCEI-1357-2012
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03071367
- Acronym / sponsor ID
- CCEI-1357-2012
- Conditions
- Educational Activities
- Keywords
- Airway Management, Medical students, Intratracheal intubation, Educational Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- 20 Aug 2012 (actual)
- Primary completion
- 20 Feb 2014 (actual)
- Study completion
- 20 Jun 2014 (actual)
- First posted
- 6 Mar 2017 (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.
Multiple studies have shown clinical simulation benefits over classical learning method. Research on simulation of airway management has focused on endotracheal intubation training, while research on ventilation via facemask is scant. The investigators compared both learning methods regarding the acquirement of basic skills for airway management by medical students. Students in the clinical simulation group received a 3-hour training on airway management on the first day of their 28-day anesthesia rotation, while classical learning did not. On the last day of rotation, participants were evaluated based on a validated instrument of scores. Primary outcome was airway management scores. Secondary outcomes were rate of success of intubation and incidence of complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Simulation | Experimental | Other: Clinical Simulation |
| Classical Learning | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Last year medical students at Universidad de los Andes
- Over 18 year old
Key exclusion criteria (2 listed)
- Previous elective anesthesia rotation
- Motor deficit affecting the upper limbs
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 |
|---|---|---|
| Clinical Simulation | Other | Clinical Simulation |
Primary outcome
Airway management score
Time frame: 28 days
2 secondary outcomes
Successful intubation rate
Time frame: 28 days
Incidence of complications
Time frame: 28 days
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 7 Mar 2017.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Simulation in people with Educational Activities, run by Fundación Santa Fe de Bogota.
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 2 inclusion and 2 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Airway management score (time frame: 28 days). 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 7 Mar 2017.