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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02263300
Other study ID # STU00098465
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date March 30, 2015

Study information

Verified date May 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date March 30, 2015
Est. primary completion date March 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Third and fourth year medical student - no previous training in fiberoptic intubation Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Elapsed time to mannequin intubation with fiberoptic scope. 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 Global rating scale (GRS) 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
Secondary Examiner check list (ECL) scores The ECL will be used to measure the students proficiency with the fiberoptic scope on a scale of 0-5 for each attempt. 2 mintues
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