Glottic View Using Supraglottic Devices in Pediatric Patients
Phase: NA
Conditions: Operative Surgical Procedures
Sponsor: Senthil G. Krishna

 
 
 
 
Glottic view using supraglottic devices in pediatric patients  
 
NCT02532465 
 
IRB Approval Date: 8/7/2015 

Glottic view using supraglottic devices in pediatric patients 
PI: Senthil G Krishna 
Co-investigators: Georgio Veneziano, Mumin Hakim, Joseph D Tobias 
 
Describe the background and rationale for this project. Reference to 
peer reviewed literature is desirable: Endotracheal intubation is the gold 
standard for securing the airway. However, while managing patients with difficult 
airways, various supraglottic devices have been used as rescue airway devices. 
Laryngeal mask airways (LMAs) are among the most commonly used supraglottic 
devices. After placement, subsequent intubation with an endotracheal tube via 
the LMA is achieved either blindly or with the use of a fiberoptic device. Several 
modifications of the LMA have been developed since its introduction in 1983 to 
improve their ease of initial use, multimodal function, and subsequent facilitation 
of ETT placement. Modifications of the classic LMA have included the intubating 
LMA (I-LMA) and variants (LMA Fastrach, Air-Q and LMA-Supreme).  
 
Another supraglottice device and variant of the LMA is known as the i-gel.  The i-
gel does not have an inflatable cuff. In the i-gel, the traditional cuff of the LMA is 
replaced with a soft, gel-like, and transparent thermoplastic elastomer (styrene 
ethylene butadiene styrene) which is a mirror impression of the 
supraglottic/periglottic anatomy and creates a non-inflatable seal.1 The unique 
features of i-gel also include a separate conduit for gastric suction, an epiglottic 
ridge, and a ridged flattened stem to aid insertion and reduce the risk of axial 
rotation, a rigid stem and a bite block.2,3 The i-gel® has also been used in 
rescue airway management and as a conduit for tracheal intubation.3-10 
 
Recently, there have been attempts to compare the various LMAs and the ease 
of subsequent intubation through the different types of LMAs in adult patients.11-
12 The aim of our current study is to compare the fiberoptic view through the 
internal aspect of the i-gel versus the Air-Q LMA in pediatric patients.  By 
examining the fiberoptic view through these two devices, we will determine 
which device provides a clearer passage to the glottic opening and is therefore 
the preferred conduit to aid endotracheal intubation in difficult airways. 
 
 
Describe the significance of the proposed research:  
Although management of the difficult airway is generally rare in the pediatric 
population, it is one of the leading causes of perioperative morbidity and 
mortality.  Simple and effective techniques to secure the difficult airway are 
needed.  This study would help define the optimal supraglottic device for that 
purpose. 
 
State the primary and secondary objectives of the study: We will 
compare the fiberoptic view of the glottic aperture by passing a fiberoptic 

bronchoscope through two types of supraglottice airways (the Air-Q LMA or the i-
gel LMA). 
  
If this research is hypothesis driven, succinctly state the hypothesis: 
The i-gel LMA will provide a better bronchoscopic view of the glottic aperature 
than the Air-Q LMA. 
  
Outline the major steps and methodologies in the clinical protocol(s).   
If necessary, include a description of any procedures being performed 
already for diagnostic or treatment purposes: General anesthesia with the 
use of an LMA or supraglottic device is routinely performed on more than half of 
the pediatric patients undergoing general anesthesia every day in our operating 
rooms.  There will be no change in the anesthetic care during these procedures; 
however, 100 patients would be randomized to one of two types of supraglottic 
devices; i-gel or LMA (Air-Q). Following placement of the supraglottic device, a 
fiberoptic bronchoscope will be inserted through the LMA to its distal end and a 
picture of the glottis aperture will be obtained.  The following scoring system will 
be used13,14: 
 
1. 
vocal cords not seen, but ventilation adequate 
 
2. 
vocal cords + anterior epiglottis 
 
3.  
vocal cords + posterior epiglottis 
 
4. 
only vocal cords seen 
  
Placement of the fiberoptic bronchoscope will be performed after the 
administration of general anesthesia and 100% oxygen to avoid any risk of 
oxygen desaturation. The procedure will take less than 15 seconds and the 
bronchoscope will not exit the distal end of the supraglottic device. Therefore, it 
will not touch the airway.  Given this, there is no additional risk although the use 
of the fiberoptic bronchoscope for the purpose of the study only. 
 
Identify the variables to be measured and how they will be statistically 
evaluated: A Fishers’ exact test and a contingency table will be used to 
compare the bronchoscopic view through the two different supraglottic devices.  
Most importantly, the percentage of acceptable/good view (grade 3 or 4) will be 
compared to poor view (grade 1).   
 
References: 
1. Levitan RM, Kinkle WC. Initial anatomic investigations of the i-gel 
airway: A novel supraglottic airway without inflatable cuff. 
Anaesthesia 2005;60:1022–6.  
2. Uppal V, Gangaiah S, Fletcher G, Kinsella J. Randomized crossover 
comparison between the i-gel and the LMA-Unique in 
anaesthetized, paralysed adults. Br J Anaesth 2009;103:882–5. 

3. Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, et al. A 
randomised trial comparing the i-gel (TM) with the LMA Classic 
(TM) in children. Anaesthesia 2012;67:606–11.  
4. Michalek P, Hodgkinson P, Donaldson W. Fiberoptic intubation 
through an i-gel supraglottic airway in two patients with predicted 
difficult airway and intellectual disability. Anesth Analg 
2008;106:1501–4.  
5. Campbell J, Michalek P, Deighan M. i-gel supraglottic airway for 
rescue airway management and as a conduit for tracheal intubation 
in a patient with acute respiratory failure. Resuscitation 
2009;80:963.  
6. Michalek P, Donaldson W, Graham C, Hinds JD. A comparison of 
the i-gel supraglottic airway as a conduit for tracheal intubation 
with the intubating laryngeal mask airway: A manikin study. 
Resuscitation 2010;81:74–7.  
7. Theiler L, Kleine-Brueggeney M, Urwyler N, Graf T, Luyet C, Greif 
R. Randomized clinical trial of the i-gel™ and Magill tracheal tube or 
single-use ILMA™ and ILMA™ tracheal tube for blind intubation in 
anaesthetized patients with a predicted difficult airway. Br J 
Anaesth 2011;107:243–50.  
8. Halwagi AE, Massicotte N, Lallo A, Gauthier A, Boudreault D, Ruel 
M, et al. Tracheal intubation through the i-gel™ supraglottic airway 
versus the LMA Fastrach™: A randomized controlled trial. Anesth 
Analg 2012;114:152–6.  
9. Francksen H, Renner J, Hanss R, Scholz J, Doerges V, Bein B. A 
comparison of the i-gel with the LMA-Unique in non-paralysed 
anaesthetised adult patients. Anaesthesia 2009;64:1118–24.  
10. Janakiraman C, Chethan DB, Wilkes AR, Stacey MR, Goodwin N. A 
randomised crossover trial comparing the i-gel supraglottic airway 
and classic laryngeal mask airway. Anaesthesia 2009;64:674–8.  
11. Kapoor S, Jethava DD, Gupta P, Jethava D, Kumar A. Comparison 
of supraglottic devices i-gel® and LMA Fastrach® as conduit for 
endotracheal intubation. Indian J Anaesth 2014;58:397-402. 
12. Theiler LG, Kleine-Brueggeney M, Kaiser D, Urwyler N, Luyet C, 
Vogt A, et al. Crossover comparison of the laryngeal mask supreme 
and the i-gel in simulated difficult airway scenario in anesthetized 
patients. Anesthesiology 2009;111:55–62. 
13. Briamacombe J, Berry A. A proposed fiber-optic scoring system to 
standardize the assessment of laryngeal mask airway placement. 
Anesth Analg 1993;76:457-459. 
14. Francksen H1, Renner J, Hanss R, Scholz J, Doerges V, Bein B. A 
comparison of the i-gel with the LMA-Unique in non-paralysed 
anaesthetised adult patients. Anaesthesia 2009;64:1118-24.