i-gel® from Intersurgical: clinical evidence listing

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

Layperson mouth-to-mask ventilation using a modified i-gel laryngeal mask after brief onsite instruction: a manikin-based feasibility trial.

Schälte G, Bomhard LT, Rossaint R, Coburn M, Stoppe C, Zoremba N, Rieg A. BMJ Open. 2016 May 12;6(5):e010770.

100 participants were presented with a manikin and an airway management package containing a labelled i-gel and a mouthpiece with a filter which connected to the i-gel connector. They were given a sheet of instruction and attempted to ventilate the manikin. Time to ventilation, success rate, i-gel position and direction, and participant age and first aid experience were recorded. Participants rated their success and the ease of use, stated whether they would use the device in an emergency, and stated whether they would feel comfortable performing ventilation with the device. The three devices were generally comparable. However, the i-gel was quicker to insert, most likely due to the lack of inflatable cuff. The incidence and severity of both perioperative and postoperative complications was low.

Link to abstract.

 

 

Comparison of learning performance of 2 intubating laryngeal mask airways in novice: A randomized crossover manikin study.

Liu ZJ, Yi J, Chen WY, Zhang XH, Huang YG. Medicine (Baltimore). 2017 May;96(19):e6905.

46 doctors with no intubation experience were given 20 minutes of airway training and a short practice session with the i-gel and Aura-I. They were then asked to insert each device into a manikin in random order and to attempt intubation through each airway. Time to ventilation, first-attempt and overall intubation success, incidence of gastric inflation, ease of insertion, view of the vocal cords, and insertion score were all recorded and compared. Participants attempted the same tasks at a 3-month follow-up session. First-attempt and overall success rates for intubation were high and comparable, with only 1 patient failing to intubate via the Aura-I at follow-up. Performance of the devices was generally comparable. Time to intubation was shorter with the i-gel at both time points. Participants also reported that the i-gel was easier to use. These results may be due to the lack of inflatable cuff.

Link to abstract

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.