Endotracheal IntubationNCT00966524
Learning and Retention of Tracheal Intubation by Medical Students: Comparison of Standard Intubation Teaching Against Video-guided Intubation Teaching.
A study testing Endotracheal intubation in people with Endotracheal Intubation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jun 2010
- 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
- Limited experience with tracheal intubation (less than 5 intubations under supervision)
- Pre-graduate medical students in their 2 clinical yea
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, H2L 4M1
About this study
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.
Read the 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.
- Conditions
- Endotracheal Intubation
- Being tested
- Endotracheal intubation
- Keywords
- Endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Teaching tracheal intubation to medical students using video-guided feedback during the procedure. Receives: Procedure: Endotracheal intubation |
| Standard | Active comparator | Teaching tracheal intubation to medical students using direct visualization feedback during the procedure. Receives: Procedure: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease to intubate (time and number of attempts required to perform intubation) and retention of the competency (short and mid-term)
Measured: Within a week and at 6 weeks
Secondary outcomes (1)
Medical students' satisfaction towards the teaching technique and their ability to perform tracheal intubation.
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- François Girard, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966524
- Sponsor's protocol ID
- FG 2010-001
- Status last verified
- Jun 2010
- First submitted
- 25 Aug 2009
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning and Retention of Tracheal Intubation by Medical Students: Comparison of Standard Intubation Teaching Against Video-guided Intubation Teaching.
- ClinicalTrials.gov ID
- NCT00966524
- Acronym / sponsor ID
- FG 2010-001
- Conditions
- Endotracheal Intubation
- Keywords
- Endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Aug 2009 (estimated)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Procedure: Endotracheal intubationTeaching tracheal intubation to medical students using video-guided feedback during the procedure. |
| Standard | Active comparator | Procedure: Endotracheal intubationTeaching tracheal intubation to medical students using direct visualization feedback during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Limited experience with tracheal intubation (less than 5 intubations under supervision)
- Pre-graduate medical students in their 2 clinical yea
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Endotracheal intubationPregraduates medical students will be randomized to perform endotracheal intubation with video-guided feedback (experimental arm) or endotracheal intubation using direct visualization feedback (standard technique). | Procedure or surgery | Standard, Video |
Primary outcome
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
1 secondary outcome
Medical students' satisfaction towards the teaching technique and their ability to perform tracheal intubation.
Time frame: At 6 weeks
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 11 Jun 2010.
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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.
François Girard, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation in people with Endotracheal Intubation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 0 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 11 Jun 2010. 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 Canada. 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?
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). 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 11 Jun 2010.