- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03071367
A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students
March 6, 2017 updated by: Leopoldo Ferrer, Fundación Santa Fe de Bogota
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Last year medical students at Universidad de los Andes
- Over 18 year old
Exclusion Criteria:
- Previous elective anesthesia rotation
- Motor deficit affecting the upper limbs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clinical Simulation
|
|
|
No Intervention: Classical Learning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Airway management score
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Successful intubation rate
Time Frame: 28 days
|
28 days
|
|
Incidence of complications
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2012
Primary Completion (Actual)
February 20, 2014
Study Completion (Actual)
June 20, 2014
Study Registration Dates
First Submitted
March 1, 2017
First Submitted That Met QC Criteria
March 3, 2017
First Posted (Actual)
March 6, 2017
Study Record Updates
Last Update Posted (Actual)
March 7, 2017
Last Update Submitted That Met QC Criteria
March 6, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CCEI-1357-2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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