i-gel® from Intersurgical: clinical evidence listing

A comprehensive list of all known published clinical evidence on the device

Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda

Pejovic N, Trevisanuto D, Lubulwa C, Myrnerts Höök S, Cavallin F, Byamugisha J,  Nankunda J, Tylleskär T. Arch Dis Child. 2018 Mar;103(3):255-260.

This phase two, single-centre, prospective, open-label RCT was carried out at the Mulago National Referral Hospital (Uganda) to assess and compare the safety and performance of the i-gel vs. the face mask (FM) during neonatal resuscitation. 50 patients were randomly assigned into two groups, the i-gel (n=25) and the FM group (m=25). Results showed that the total ventilation time was shorter in the I-gel group compared to the FM one mean 93 vs. 140s, p=0.02). All interventions were successful in the I-gel group, but 11 patients from the FM group were transferred to the I-gel one after 150s. In addition, the mean time to spontaneous breathing was 153s (SD59) with the I-gel and 216s with the FM (SD92) (p=0.005). The study estimated a 31% (95%CI 11 to 44%) reduction in spontaneous breathing when using i-gel. No adverse events were reported when using i-gel (e.g. laryngospasm, bleeding or vomiting), but two patients suffered hypoxic ischaemic encephalopathy in the FM group, and one died within the first 48 hours of life. Thus, the use of a cuffless LMA device may help in reducing the time of spontaneous breathing in neonatal resuscitation compared to FM devices.

Link to abstract.

Protection afforded by respirators when performing endotracheal intubation using a direct laryngoscope, GlideScope®, and i-gel® device: A randomized trial

Kang H, Lee Y, Lee S, Song Y, Lim TH, Oh J, Lee J, Shin H. PLoS One. 2018 Apr 19;13(4):e0195745

This study carried out an investigation on the use of two respirators (fold- and cup-type) by physicians (n=26) as protection against infections during intubation procedures with three different devices (DL, GlideScope and i-gel). Results showed a lower protection level when wearing the cup-type respirator during intubation with DL (75%) compared to GlideScope (100%) and i-gel (100%). Therefore, the type of airway device selected for intubation may impact on the level of protection of certain types of respirators. However, due to the limited number of respirators tested and the small sample size, additional larger studies are needed to validate these results.

Link to abstract.

Pre-hospital i-gel blind intubation for trauma: a simulation study

Kim JG, Kim W, Kang GH, Jang YS, Choi HY, Kim H, Kim M. Clin Exp Emerg Med. 2018 Mar 30;5(1):29-34. 

This prospective randomised crossover study was carried out to evaluate the performance and efficacy of the i-gel blind intubation (IGI) in airway management for pre-hospital trauma patients. Here, two blind intubation techniques were assessed (by 18 paramedics) using two supraglottic airway devices (IGI and LMA Fastrach) and a Macintosh laryngoscope (MCL).

Link to abstract.

I-gel™ May be the Device of Choice for Controlled Ventilation in Patients with Hemophilia Undergoing Abdominal Laparoscopic Surgery

Sen S, Mitra K, Ganguli S, Mukherji S. Anesth Essays Res. 2018 Jan-Mar;12(1):288-290

Peri-operative management of patients with haemophilia involves the risks of excessive bleeding. This is especially true when securing the patient’s airways during anaesthesia with standard instrumentation (e.g. direct laryngoscopy), as this could lead to severe haemorrhage. Therefore, this case study assessed the efficacy of the i-gel in the airway management of a patient with haemophilia undergoing laparoscopic cholecystectomy.

Link to abstract.

A comparison of i-gel™ and Laryngeal Mask Airway Supreme™ during general anesthesia in infants.

Lee YC, Yoon KS, Park SY, Choi SR, Chung CJ. Korean J Anesthesiol. 2018 Feb;71(1):37-42. 

In this study the performance of the i-gel and the LMA Supreme was evaluated in infants (ASA I and II) undergoing general anaesthesia. 60 patients were randomly assigned to the i-gel and the LMAS and the size of the devices was selected in accordance to the infant’s weight. A range of parameters including oropharyngeal leak pressure (primary outcome), fiberoptic view, airway quality, airway manipulations, insertion success rate and time (secondary outcomes) were investigated to determine the efficacy and safety of the two devices. Insertion time was shorter for the i-gel group.

Link to abstract.