A Comparative Study of Inflatable (Ambu® AuraGain™) and Non-Inflatable (i-gel®) Second-Generation Supraglottic Airway Devices in Pediatric Patients: A Prospective Randomized Clinical Trial

Abstract

Background & Objective:  Efficient airway management is paramount in pediatric anesthesia. Second-generation supraglottic airway devices (SADs) with integrated gastric channels offer significant safety advantages over first-generation designs. This study aimed to compare the insertion dynamics, sealing efficacy, and clinical performance of an inflatable cuff device (Ambu® AuraGain™) versus a non-inflatable gel cuff device (i-gel®) in pediatric patients undergoing elective surgical procedures.

Methodology:  A prospective, randomized, controlled clinical study was conducted involving 50 pediatric patients (ASA Physical Status I–II, age 1–12 years, weight 10–30 kg) allocated into two equal groups of 25 patients each: Group A (Ambu® AuraGain™) and Group B (i-gel®). Primary outcome measures included insertion time, overall and first-attempt success rate, airway maneuvers required, and oropharyngeal leak pressure (OLP). Secondary outcome measures included intraoperative hemodynamic responses and postoperative airway complications (sore throat, blood on device, or cough). Continuous variables were analyzed using independent sample t-tests and categorical data via Pearson's chi-square test.

Results:  Group B (i-gel®) demonstrated a significantly shorter mean insertion time compared to Group A (Ambu® AuraGain™) (24.12 ± 3.18 s vs. 29.84 ± 4.02 s; p < 0.001). The first-attempt success rate was comparable between groups (92.0% in i-gel® vs. 88.0% in AuraGain™; p = 0.637), with overall insertion success reaching 100% in both cohorts without device failure. However, Group A achieved a significantly higher mean OLP than Group B (19.24 ± 2.45 cmH₂O vs. 17.68 ± 2.11 cmH₂O; p = 0.021). Patients in Group A required significantly more supplementary airway manipulations to achieve adequate ventilation (48.0% vs. 20.0%; p = 0.037). Both groups demonstrated stable hemodynamic profiles with negligible postoperative complications.

Conclusion:  Both second-generation supraglottic devices provide safe and reliable airway preservation in pediatric patients. The non-inflatable i-gel® offers faster placement and requires fewer positioning maneuvers, making it exceptionally well-suited for brief elective procedures. Conversely, the inflatable Ambu® AuraGain™ achieves higher airway sealing pressures, making it the preferred choice when superior mucosal seal is needed, such as in laparoscopic procedures or controlled positive-pressure ventilation.