Pediatric supraglottic airway devices in clinical practice: A prospective observational study.

Abstract

BACKGROUND

Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™.

METHODS

This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH2O ± 10%.

RESULTS

None of the SGA showed a mean airway leak pressure of 20 cmH2O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH2O, Air-Q® 15.9 (3.2) cmH2O, Ambu® Aura-i™ 17.3 (3.7) cmH2O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™, <p = 0.005). Insertion was rated easiest with the LMA Supreme™ (very easy in 97% vs. Air-Q® 70%, Ambu® Aura-i™ 72%, p < 0.001). Fiberoptic view was similar between the SGA. Adverse events were rare.

CONCLUSIONS

Airway leak pressures ranged from 16 to 18 cmH2O, enabling positive pressure ventilation with all successful SGA. The highest success rates were achieved by the LMA Supreme™, which was also rated easiest to insert.

TRIALS REGISTRATION

ClinicalTrials.gov , identifier NCT01625858 . Registered 31 May 2012.