- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966524
Learning and Retention of Tracheal Intubation by Medical Students: Comparison of Standard Intubation Teaching Against Video-guided Intubation Teaching.
Purpose: This study is designed to assess the impact of teaching tracheal intubation using video-guided feedback on the ability to perform and maintain this clinical skill by medical students.
Hypothesis: We hypothesise that, for novices, video-guided feedback provided during tracheal intubation will improve learning and retention of this clinical skill compared to standard teaching using direct visualization feedback.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
Competency in laryngoscopic tracheal intubation is a key skill to be developed during the training of medical students. Teaching this technical skill remains a challenge due to the fact that the laryngeal view is limited to one person at a time. Therefore, the feedback given during the procedure by the instructor to the student becomes limited, delayed and thus less efficient. This lack of efficiency could explain the poor success rates of tracheal intubations performed by medical students during the initial learning phase. Over the last ten years, new intubation devices incorporating optic fibers have been commercialized. These new technologies combined to video systems are now increasingly used for teaching purposes. Recent literature tends to show that this new approach could ease the learning process and increase the medical student's satisfaction towards the teaching of tracheal intubation.
Maintaining this knowledge and clinical skill can also be challenging especially for physicians who are not exposed to the intubation technique on a regular basis. Since tracheal intubation is a potentially lifesaving procedure, retention of this competency is crucial.
This study is designed to assess the impact of teaching tracheal intubation using video-guided feedback and the short and mid-term retention of the competency in a population of pregraduate medical students (clinical years 3 and 4).
Methods:
-Initial phase:
Medical students enrolled in this study will initially receive standardised training using a short video explaining the tracheal intubation technique. Then, they will be asked to intubate on mannequins for a short period of time (15 minutes).
A total of 18 medical students will be randomly assigned to the following groups:
- Group V: to perform video-guided intubations on six patients under the supervision of an anaesthesiologist.
- Group S: to perform tracheal intubation on six patients under the supervision of an anaesthesiologist using standard teaching technique (direct visualization).
Patients scheduled for elective surgery under general anaesthesia including neuromuscular blockade as part of their anaesthetic management will be considered for this study. Standard monitoring for general anaesthesia will be used. Immediately after induction of general anaesthesia, the anaesthesiologist will confirm the patient's intubation grade. Patients having an intubation grade higher than 2 on the Cormack-Lehane scale, will be excluded.
-Short-term phase (within a week from the initial phase):
Novices will be asked to perform ten tracheal intubations under the supervision of an anaesthesiologist but without any specific feedback.
-Mid-term phase (6 weeks after the initial/short-term phase):
Novices will be asked to perform ten tracheal intubations six weeks after the initial/short term phase under the supervision of an anaesthesiologist without any specific feedback. If the medical student fails to intubate the patient, the anaesthesiologist will perform the technique.
Images from all intubations will be captured on videotape for subsequent review. These images will be used to detect mucosa lacerations, oesophageal intubation, number of attempts and total time required to perform tracheal intubation.
Lastly, a questionnaire will be completed by all medical students to assess their satisfaction towards the teaching technique and their ability to perform tracheal intubation.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Limited experience with tracheal intubation (less than 5 intubations under supervision)
- Pre-graduate medical students in their 2 clinical yea
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video
Teaching tracheal intubation to medical students using video-guided feedback during the procedure.
|
Pregraduates medical students will be randomized to perform endotracheal intubation with video-guided feedback (experimental arm) or endotracheal intubation using direct visualization feedback (standard technique).
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Active Comparator: Standard
Teaching tracheal intubation to medical students using direct visualization feedback during the procedure.
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Pregraduates medical students will be randomized to perform endotracheal intubation with video-guided feedback (experimental arm) or endotracheal intubation using direct visualization feedback (standard technique).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ease to intubate (time and number of attempts required to perform intubation) and retention of the competency (short and mid-term)
Time Frame: Within a week and at 6 weeks
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Within a week and at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medical students' satisfaction towards the teaching technique and their ability to perform tracheal intubation.
Time Frame: At 6 weeks
|
At 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: François Girard, MD, Centre hospitalier de l'Université de Montréal (CHUM)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FG 2010-001
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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