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

Anaesth Intensive Care. 2004 Feb;32(1):66-72. doi: 10.1177/0310057X0403200110.

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 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anesthesia, General / instrumentation*
  • Equipment Design
  • Female
  • Humans
  • Laryngeal Masks* / adverse effects
  • Laryngeal Masks* / economics
  • Middle Aged
  • Outcome Assessment, Health Care
  • Pharyngitis / etiology
  • Single-Blind Method