i-gel® from Intersurgical: clinical evidence listing

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

How do different brands of size 1 laryngeal mask airway compare with face mask ventilation in a dedicated laryngeal mask airway teaching manikin?

Tracy MB, Priyadarshi A, Goel D, Lowe K, Huvanandana J, Hinder M. Arch Dis Child Fetal Neonatal Ed. 2018 May;103(3)

This manikin study assessed and compared the delivered ventilation of seven, size 1 LMA devices with two different face masks using self-inflating bags (SIBs). 40 participants carried out resuscitation on a specialised infant training manikin using the LMAs and the face masks in a random fashion. Findings have shown that the i-gel had the highest peak inspiratory pressure and higher PEEP compared to the other devices. In addition, the i-gel showed no insertion failures and all users described it as easy to use. Thus, these results indicate that the i-gel may become the primary resuscitation device used for newborn resuscitation.

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.

Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low-resource settings

Pejovic NJ, Trevisanuto D, Nankunda JJ, Tylleskar T. Acta Paediatr. 2016 Dec;105(12):1440-1443

After brief training, 25 participants attempted insertion, with success rate and insertion time recorded. i-gel achieved 100% insertion success rate and was more effective than the face mask in establishing PPV.

Link to abstract.

Supraglottic airway devices during neonatal resuscitation: An historical perspective, systematic review and meta-analysis of available clinical trials

Schmolzer GM, Agarwal M, Kamlin CO, Davis PG. Resuscitation 2013; 84(6): 722-30

Review of available literature on the use of supraglottic airway devices during neonatal resuscitation. Current evidence suggests that resuscitation with a laryngeal mask is a ‘feasible and safe alternative to mask ventilation in infants’, however further randomised controlled trials are needed.

Abstract text