i-gel® from Intersurgical: clinical evidence listing

Dhanda A, Singh S, Bhalotra AR, Chavali S. Turk J Anaesthesiol Reanim. 2017 Oct;45(5):270-276

The adequacy of i-gel for pressure-controlled ventilation (PCV) in 60 patients undergoing elective surgery was assessed in this study. Patients were randomly assigned to the i-gel group or cuffed tracheal tube group. Several parameters were evaluated such as insertion time, number of attempts, ease of insertion and performance of the cardiovascular system. Furthermore, air leak, leak volume, leak fraction and pharyngolaryngeal (PL) morbidity were also assessed. Findings have shown that i-gel was easier to insert compared to the tracheal tube. Heart rate and mean arterial pressure were higher following tracheal tube but comparable between the two groups after few minutes. Moreover, the leak volume and leak fraction were comparable between the two groups at 15 cm H2O but significantly different at 20 and 25 cm H2O (higher in the i-gel group), and PL morbidity was significantly higher in the tracheal tube. Therefore, the i-gel represents a valuable alternative to the cuffed ETT if pressure is limited to 15 - 20 cm H2O.

Link to abstract.

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.