Proseal Laryngeal Mask Gel vs I-gel- A Randomised Clinical Trial among Paediatric Patients

Abstract

Introduction: A Supraglottic Airway Device (SAD) is placed above the larynx to form a seal around it. SADs like paediatric Proseal Laryngeal Mask Airway (P-LMA) and I-geltm are increasingly used in recent times. Aim: To compare the efficacy of paediatric P-LMA and I-gel in clinical practise. Materials and Methods: After obtaining ethical committee clearance and parent/guardian consent, 60 paediatric patients aged 2-12 years belonging to ASA grade I and II posted for elective surgeries under general anaesthesia, were included in the study. After induction of general anaesthesia, either of the SAD was inserted and study parameters namely ease and number of attempts of insertion of the device, ease of insertion of gastric tube, leak airway pressure, efficacy during positive pressure ventilation and postoperative complications were evaluated. Statistical comparison was performed by repeated measures of variance followed by Unpaired Student t-test and Chi-square test. A probability value p-value less 0.05 was regarded as statistically significant. Results: The device was easily inserted in 90% of the patients in both study groups (p-value 0.99). In P-LMA group, the device was inserted in first attempt in 83.33% against 90% in the I-gel group (p-value 0.70). In P-LMA group, gastric tube insertion was graded easy in 80% children while in I-gel group it was 90% children (p-value 0.47). The leak airway pressure measured at two different time intervals was statistically insignificant. Intra-operative dislodgement of the device was noted in one child in each group. Postoperative complications like sore throat and dysphagia were reported in four and two children, respectively in P-LMA group, while it was reported in two and one child in the I-gel group. Complications with P-LMA and I-gel were statistically insignificant. Conclusion: Paediatric P-LMA and I-gel are safe and non-invasive methods of securing the airway with regard to clinical safety parameters and hence can be used in paediatric population.