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.

Competence in the use of supraglottic airways by Australian surf lifesavers for cardiac arrest ventilation in a manikin

Holbery-Morgan L, Angel C, Murphy M, Carew J, Douglas F, Murphy R, Hood N, Rechtman A, Scarff C, Simpson N, Stewardson A, Steinfort D, Radford S, Douglas N, Johnson D. Emerg Med Australas. 2017 Feb;29(1):63-68

Lifesavers in Australia who already use pocket masks and BVMs were trained to use the LMA and i-gel on a manikin. Time to effective ventilation was similar between the pocket mask, BVM and i-gel, but longer for LMA. Authors feel there is a limited role for supraglottic airway devices in this scenario.

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.

Addressing the challenges of paramedic recruitment and engagement in Airways-2

Pilbery R, Green J, Hall H, Whitley G. Emerg Med J 2016; 33e12

Report into the three main challenges facing recruitment for the Airways-2 trial (comparison of i-gel against tracheal intubation in patients suffering OHCA). 

Link to abstract.

Design and implementation of the AIRWAYS-2 trial

Taylor J, Black S, Brett S, Kirby K, Nolan JP, Reeves BC, Robinson M, Rogers CA, Scott LJ, South A, Stokes EA, Thomas M, Voss S, Wordsworth S, Benger JR. Resuscitation. 2016 Sep 30. pii: S0300-9572(16)30476-2

Patient enrollment began in June 2015 for this study comparing the use by paramedics of the i-gel against endotracheal intubation in OHCA in the UK. The primary outcome is the modified Rankin Scale score at hospital discharge. The trial will enrol 9070 patients over two years.

Link to abstract.