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.

Sore throat following three adult supraglottic airway devices

L'Hermite J, Dubout E, Bouvet S, Bracoud LH, Cuvillon P, Coussaye JE, Ripart J. Eur J Anaesthesiol. 2017 Jul;34(7):417-424

Comparison of the incidence of sore throat in 546 patients following use of LMA Unique, LMA Supreme and the i-gel. Primary outcome was incidence 24 hours postoperatively. Authors concluded that recordings were not significantly different between the three devices.

Link to abstract

Ambu AuraOnce versus i-gel laryngeal mask airway in infants and children undergoing surgical procedures. A randomized controlled trial

Alzahem AM, Aqil M, Alzahrani TA, Aljazaeri AH. Saudi Med J. 2017 May;38(5):482-490

Randomised assignment of 112 patients to either AuraOnce or i-gel groups in which oropharyngeal leak pressure, ease of insertion and fibreoptic viewing were measured. i-gel recorded more favourable leak pressures and superior fibreoptic viewing.

Link to abstract.

Are nurses able to perform blind intubation? Randomized comparison of I-gel and laryngeal mask airway

Ladny JR, Bielski K, Szarpak L, Cieciel M, Konski R, Smereka J. Am J Emerg Med. 2017 May; 35(5): 786-787

Manikin study to assess effectiveness of blind intubation through the i-gel, LMA Classic and a standard cuffed tracheal tube, performed by 34 nurses in CPR conditions across two scenarios (with and without chest compressions). Primary measure was time to intubation. i-gel recorded a lower median time to intubation and higher, statistically significant, successful insertion rates in both scenarios. Performing compressions doesn't significantly affect time to perform blind intubation in this setting, but reduces the effectiveness of first intubation attempt. i-gel was faster in both scenarios.

Link to abstract.

Comparison of the Macintosh laryngoscope and blind intubation via the iGEL for intubation with cervical spine immobilization: A randomized, crossover, manikin trial

Gawlowski P, Smereka J, Madziala M, Szarpak L, Frass M, Robak O. Am J Emerg Med. 2017 Mar; 35(3): 484-487.

Paramedics performed standard intubation and blind intubation in three airway scenarios. Results show that blind intubation with the i-gel was superior to ETI performed by paramedics.

Link to abstract.