Randomized Evaluation of the Single-use SoftSeal™ and the Re-useable LMA Classic™ Laryngeal Mask

Abstract

A number of laryngeal masks are available, including both re-usable and single-use masks. Single-use laryngeal masks may decrease the risk of transmitting prion infections. We performed a single-blind randomized trial in 200 spontaneously breathing female patients under general anaesthesia with nitrous oxide, to compare a new single-use laryngeal mask, the SoftSeal™ (Portex Ltd, U.K.), with a re-usable laryngeal mask, the LMA Classic™ (Laryngeal Mask Company Ltd., Cyprus). The primary outcome was successful insertion at the first attempt. Size 4 single-use (n=99) or re-usable (n=100) laryngeal masks, inserted by experienced anaesthetists, were equivalent for successful placement at the first attempt (90% versus 91% respectively). The single-use mask was less easy to insert (47% difficult versus 9%, P<0.001). Clinical and anatomical tests of position and function were similar. The cuff pressure of the re-usable mask increased significantly compared with the single-use mask (median +10 cm versus –2 cm H 2 O, P<0.001). Forty per cent of patients allocated the single-use mask and 20% of those allocated the re-usable mask experienced sore throat at 24 hours postoperatively (P<0.05). An estimation of cost per patient use was greater for the re-usable mask. We conclude that the SoftSeal™ single-use laryngeal mask and the LMA Classic™ re-usable laryngeal mask airway are of similar clinical utility in terms of successful insertion and airway maintenance. The re-usable laryngeal mask was easier to insert and associated with less postoperative sore throat, but costs were higher.