- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02263300
Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Does Spatial Orientation Affect the Rate of Learning Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on the development of fiberoptic intubation skills?
Is it necessary to teach both orientations or is the supine view transferable to the upright position?
Which method demonstrates longer skill retention?
The hypotheses: Both orientations must be practiced and the upright skill is harder to learn but is retained for longer.
Study Overview
Status
Conditions
Detailed Description
Following IRB approval, written consent to participate in the study will be obtained from medical students
Phase one :
Forty medical students, novices in fiberoptic intubation use will be recruited and randomly assigned into one of two groups:
Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions.
Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINEposition.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions.
Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
teaching testing testing week testing testing
Group A supine supine upright random random random random B upright upright supine random random random random C supine upright supine random random random random D upright supine upright random random
Phase two:
Study candidates will randomly be assigned(20 per group) to practice for 15minutes/day their intubations skills with the iLarynx application downloaded to their smart phones or iPads. The other group (20candidates) will be asked not to practice their intubation skills. At the end of one week both groups will be retested on a mannequin by the same blinded examiner to obtain a new learning curve, global assessment score and checklist. Both orientations of the mannequin will be tested and the order randomly assigned.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Third and fourth year medical student
- no previous training in fiberoptic intubation
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Supine- Supine
Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position.
Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position.
At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions.
|
Upright-upright
Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position.
Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
|
Supine -upright
Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position.
Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position.
At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions.
|
Upright - supine
Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position.
Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position.
At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elapsed time to mannequin intubation with fiberoptic scope.
Time Frame: 2 minutes
|
The elapsed time of intubation with fiberoptic scope of a mannequin.
Stop watch is started at passing teeth and ends when scope reaches carina.
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global rating scale (GRS)
Time Frame: 2 minutes
|
Global rating scale (GRS) and assessment of medical students skill demonstrated during fiberoptic intubation of a mannequin on a score of 1-5 1 being very poor and 5 being clearly superior.
|
2 minutes
|
Examiner check list (ECL) scores
Time Frame: 2 mintues
|
The ECL will be used to measure the students proficiency with the fiberoptic scope on a scale of 0-5 for each attempt.
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2 mintues
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raymond Glassenberg, MD, Northwestern University
Publications and helpful links
General Publications
- Badurdeen S, Abdul-Samad O, Story G, Wilson C, Down S, Harris A. Nintendo Wii video-gaming ability predicts laparoscopic skill. Surg Endosc. 2010 Aug;24(8):1824-8. doi: 10.1007/s00464-009-0862-z. Epub 2010 Jan 28.
- Boet S, Bould MD, Schaeffer R, Fischhof S, Stojeba N, Naik VN, Diemunsch P. Learning fibreoptic intubation with a virtual computer program transfers to 'hands on' improvement. Eur J Anaesthesiol. 2010 Jan;27(1):31-5. doi: 10.1097/EJA.0b013e3283312725.
- De Oliveira GS Jr, Glassenberg R, Chang R, Fitzgerald P, McCarthy RJ. Virtual airway simulation to improve dexterity among novices performing fibreoptic intubation. Anaesthesia. 2013 Oct;68(10):1053-8. doi: 10.1111/anae.12379. Epub 2013 Aug 19.
- Goldmann K, Steinfeldt T. Acquisition of basic fiberoptic intubation skills with a virtual reality airway simulator. J Clin Anesth. 2006 May;18(3):173-8. doi: 10.1016/j.jclinane.2005.08.021.
- Chandra DB, Savoldelli GL, Joo HS, Weiss ID, Naik VN. Fiberoptic oral intubation: the effect of model fidelity on training for transfer to patient care. Anesthesiology. 2008 Dec;109(6):1007-13. doi: 10.1097/ALN.0b013e31818d6c3c.
- Marsland CP, Robinson BJ, Chitty CH, Guy BJ. Acquisition and maintenance of endoscopic skills: developing an endoscopic dexterity training system for anesthesiologists. J Clin Anesth. 2002 Dec;14(8):615-9. doi: 10.1016/s0952-8180(02)00456-7.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00098465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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