A clinical evaluation of the I-gel ™ supraglottic airway device in children.

Background: The i-gel(TM) is one of the latest commercially available, second-generation supraglottic airway devices (SADs). Specific features include a distal cuff made of a thermoplastic elastomer gel that does not require inflation and a gastric side channel to allow passage of a gastric tube, venting of gas from the stomach, and an early indication of regurgitation. Previous studies in older children and adults have shown that it is a reliable, efficient, and safe device for airway management.

Methods: We evaluated the i-gel(TM) in sizes ranging from 1 to 2.5 in children considered suitable for a supraglottic device. We assessed successful rates of insertion, airway leak pressure, position confirmed by fiberoptic laryngoscopy, gastric tube placement, manipulations required, and complications.

Results: The i-gel(TM) was used in 154 children over a period of 12 months. The median age [interquartile range (IQR)] was 4 years 11 months (2-7 years), median weight (IQR) 19 kg (13-26), and median (IQR) duration of procedure 29 (30-45) min. First insertion attempt was successful in 93.5% of patients, and second attempt in 5.8%. The median (IQR) time to insertion was 14 (13-16) s. The median (IQR) leak pressure was 20 (15-25) cmH(2) 0. Gastric tube placement was successful in 90% of cases. On fiberoptic examination, the vocal cords were visible in 97% of patients. Complications arose in 20% of patients, but the majority were minor. Anesthetists commented that the device had a tendency to displace upward out of the mouth and that extension toward the forehead and flexion toward the feet of the proximal tube altered the quality of the airway. Overall, in seven (4.5%) patients, the device was abandoned and an alternative airway was used.

Conclusions: Pediatric i-gel(TM) sizes 1.5-2.5 provided a satisfactory airway during anesthesia for spontaneously breathing infants and children. However, to ensure a clear airway, considerable vigilance is required when fixing the device in the mouth and to avoid the negative effects of flexion of the proximal tubing. The i-gel(TM) is more expensive than first-generation devices. Whether this additional cost for the potential benefit of greater airway protection is considered acceptable will depend on longer-time evaluation and surveillance to establish overall safety.