Does Spatial Orientation Affect the Rate of Learning Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Conditions: Airway Management
Sponsor: Northwestern University

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
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Date  11/12/2014 V 1.1 
IRB # STU00098465 
Proposed Research Protocol Form 
Northwestern University Medical School 
Department of Anesthesiology Research Committee 
Title: Does Spatial Orientation Affect the Rate of Learning Fiberoptic Intubation 
Skills in the Novice: A Randomized Controlled Trial     
Principal Investigator: Raymond Glassenberg, M.D. 
Co-investigators: Robert McCarthy, Paul Fitzgerald                             
                             
Affiliation:  Department of Anesthesiology 
Northwestern University Feinberg School of 
Medicine Institution: Northwestern Memorial Hospital  
Research Aims:  
1. Research Questions(s) (1) Does spatial orientation of a novice in relation to a 
mannequin (supine vs upright) impact on the development of fiberoptic intubation  
skills (2) Is it necessary to teach both orientations or is the supine view 
transferable to the upright position. (3) Which method demonstrates longer skill 
retention. 
2. Hypotheses   (1) Both orientations must be practiced. (2) The upright skill is 
harder to learn but is retained for longer.  
Research significance: 
Background: With the introduction of the Glidescope in the 2000’s, fiberoptic skills 
are not practiced as frequently as in the past. We are frequently challenged with 
difficult airways in both the operating room and ICU. Patients with adult epiglottitis, 
upper airway tumors, severe OSA, CHF present sitting up frequently drooling 
because the added weight of the lung helps “tent open” the airway. These patients are 
not Glidescope candidates.   Currently, a mannequin consisting of a rubber model 
mold of the airway is the only cost effective training tool that can be used by the 
novice to develop the necessary hand-eye co-ordination skills needed for successful 
fiberoptic intubation. Virtual reality systems that incorporate a real bronchoscope 
handle interfaced with a computer and monitor could represent an ideal teaching tool, 
but are expensive. The Orsim trainer can provide fibroptic training in both the supine 
and upright positions, but costs  $18,000. We developed a simple, inexpensive 
application, iLarynx, for the iPhone or iPad that gives the novice the ability to 
practice fiberoptic intubation without going to a designated skills lab.  A recent 
MEDLINE review of the literature concludes that training on nonspecific video 

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
Page 2 of 8 
Date  11/12/2014 V 1.1 
IRB # STU00098465 
games improves endoscopic performance of novices when tested on simulators. The 
iLarynx is available for free at the iphone app store . At present, over 75,000 copies 
were distributed worldwide. Our study, that the iLarynx helps improve acquisition of 
the skills needed for fiberoptic intubation, was accepted for publication in the journal 
Anaesthesia. 
Significance:  
Novices better prepared in the skills of manipulating a fiberoptic will take less time 
and have a higher success rate of fiberoptic intubation. These skills must be taught for 
both spatial orientations and practiced to be retained  
Investigational Plan: 
Following IRB approval, written consent to participate in the study will be obtained 
from medical students  
Phase one : 
Sixty 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 supine position. 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 

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
Page 3 of 8 
Date  11/12/2014 V 1.1 
IRB # STU00098465 
end of one week, the same medical student will then perform the intubation with the 
mannequin in both positions. 
  
teachin 
g 
    
testing 
testing 
  week 
testing 
testing 
  
  
    
  
  
    
  
  
  
  
    
  
  
    
  
  
A 
supine 
    
supine 
upright 
  i/droid 
upright 
supine 
  
  
    
  
  
    
  
  
B 
upright 
    
upright 
supine 
  i/droid 
supine 
upright 
  
  
    
  
  
    
  
  
C 
supine 
    
upright 
supine 
  i/droid 
upright 
supine 
  
  
    
  
  
    
  
  
D 
upright 
    
supine 
upright 
  i/droid 
upright 
supine 
Phase two:  
Sudy 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. 
Statistical Methods: 
60 medical students will be consented to allow for dropout. Based on a repeated – 
measures design with one between-factor design (supine vs upright) and one within 
factor (repetitions), four groups with 10 subjects each with each subject measured 10 
times, achieves 87% power to measure a difference in time to visualize the carina 
using  a Geisser -Greenhouse Corrected F-test at a 5% significance level assuming an 
effect size of 0.7. Groups A ,B,C,D will be compared.  The two outcome measures 
global rating scale (GRS) and examiner check list (ECL) scores will be analyzed 
using a two-way, mixed design ANOVA. Categorical data such as success failure will 
be analyzed by Fisher exact test. Time to intubation will be analyzed using the 
MannWhitney U test. 
Inclusion Criteria: 
Medical Student: 
      Inclusion criteria for the medical student: 
      -Medical student or intern rotating through the anesthesiology department 
       

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
Page 4 of 8 
Date  11/12/2014 V 1.1 
IRB # STU00098465 
      Exclusion criteria for the medical student: 
- Previous  fiberoptic training 
- Refuses participation 
Risks/Benefits: 
There is a risk of loss of confidentiality for the medical student. The medical student may 
feel anxious performing tasks while being evaluated.  The benefit of this study is that the 
students may benefit by acquiring more quickly the skill set needed for fiberoptic 
intubation of a mannequin. 
Confidentiality: 
The medical students’ identity will be guarded by assigning a numerical code which is 
only known by the principal investigator.  Data is stored in a department computer which 
is password protected.   Subject data will be stored on secure computers at Northwestern 
University.  Data access will be password protected and only available to study 
investigators. The data forms are only identified using study code number. Data will be 
destroyed 7 years post manuscript acceptance. The departmental protocol will be followed 
using current vendors for paper and electronic record destruction.   
 
 
Virtual vallecular cyst 
Real vallecular cyst 
                       Figure 1:    iLarynx 

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
Page 5 of 8 
Date  11/12/2014 V 1.1 
IRB # STU00098465 
 
 
 Figure 2 iLarynx 
supine view 

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
Page 6 of 8 
Date  11/12/2014 V 1.1 
IRB # STU00098465 
Figure 3 : orientation (supine vs upright) 
 
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Anaesthesiol 2010;27:31-5. PMID: 19851113 
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Lynch J, Aughwane P, Hammond TM. Video games and surgical ability: a literature review. J 
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Marsland CP, Robinson BJ, Chitty CH, Guy BJ. Acquisition and maintenance of endoscopic 
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Naik VN, Matsumoto ED, Houston PL, Hamstra SJ, Yeung RY, Mallon JS, Martire TM. 
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simple model transfer into the operating room? Anesthesiology 2001;95:343-8. PMID: 11506104 
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Rowe R, Cohen RA. An evaluation of a virtual reality airway simulator. Anesth Analg 
2002;95:62- 

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
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6. PMID: 12088944 
9. 
DeOliveira GS, Glassenberg R, Fitzgerald P, McCarthy RJ, Virtual airway simulation to improve 
dexterity among novices performing fiberoptic intubation Anaesthesia 2013,68; 1053-1058 
                     
          
 

IRB #: STU00098465-MOD0001 Approved by NU IRB for use on or after 3/12/2015 through 7/22/2015. 
R. Glassenberg, M.D.    
Page 8 of 8 
Date  11/12/2014 V 1.1 
IRB # STU00098465 
 
Consent:  Attached