Randomized evaluation of the single-use SoftSeal and the re-useable LMA Classic laryngeal mask

• Published in: Anaesthesia and intensive care 2004-02, Vol.32 (1), p.66-72
• Main Authors: PAECH, M. J, LAIN, J, GARRETT, W. R, GILLESPIE, G, STANNARD, K. J. D, DOHERTY, D. A
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Anesthesia; Anesthesia, General - instrumentation; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Equipment Design; Female; Humans; Laryngeal Masks - adverse effects; Laryngeal Masks - economics; Medical sciences; Middle Aged; Outcome Assessment (Health Care); Pharyngitis - etiology; Single-Blind Method
• ISSN: 0310-057X; 1448-0271
• DOI: 10.1177/0310057x0403200110

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 H2O, 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.