A randomised comparison of the Portex Softseal^™ laryngeal mask airway with the LMA‐Unique^™ during anaesthesia

Abstract

Summary We have compared the performance of the single use laryngeal airway devices Softseal™ and LMA‐Unique™ in a randomised comparative trial in anaesthetised healthy patients who did not receive neuromuscular blockade. Primary outcome was success of airway placement. Secondary outcomes included manipulations and complications during use, ease of insertion, airway and fibreoptic assessment of airway positioning, and complications postoperatively. We planned to study 300 patients but interim analysis demonstrated the study should be stopped after 100 patients. During insertion the Softseal™ required more attempts for successful insertion (p = 0.041), more manipulations (p < 0.0001) and caused more complications (p = 0.048). Failure of placement occurred in five cases with the Softseal™ and none with the LMA‐Unique™ (p = n/s). Two Softseal™ needed to be removed during maintenance because of airway obstruction, giving an overall failure rate of seven (p = 0.013). Serial tests of positioning favoured the LMA‐Unique™ (p = 0.012). Ventilation was more successful in the LMA‐Unique™ group but the difference was not significant (p = 0.051). Seal pressure was higher with the Softseal™ (26.5 vs. 20.5 cmH2O, p = 0.005). Fibreoptic view via the devices was not statistically significantly different. During maintenance of anaesthesia more complications arose with the Softseal™ (p = 0.03). Anaesthetist ratings of ease of insertion and overall usefulness favoured the LMA‐Unique™ (p < 0.0001 and p = 0.024, respectively). After anaesthesia, sore throat occurred more frequently and was more severe in those patients anaesthetised with a Softseal™ both in recovery (p = 0.015) and at 24 h (p = 0.012). We conclude that the Softseal™ performs less well and causes more complications than the LMA‐Unique™.

A comparison of usage of the laryngeal mask UniqueTMin denticulate and edentulate geriatric patients

“…The OLP values observed in our study were similar to those found in the studies of López et al (12), van Zundert et al (29), and Cook et al (30) when the cuff inner pressure was maintained at 60 cmH 2 O, i.e. 22 ± 6, 25 ± 6, and 20.5 cmH 2 O, respectively.…”

A clinical evaluation of four disposable laryngeal masks in adult patients

“…Clinical comparisons of the LMA Unique and Soft Seal have been reported by Brimacombe et al [16], Cook et al [18], and Paech et al [17], and all of the investigators found that the LMA Unique was the easier to insert in expert hands. In contrast, van Zundert et al [23] found no differences between the LMA Unique and Soft Seal when compared with the CobraPLA.…”

“…3). Some studies have assessed its clinical performance compared with that of the LMA Classic [12][13][14][15] and the LMA Unique [16][17][18], with varying results. The Solus has the same sizes and design as the LMA Unique, except without epiglottic bars (Solus Laryngeal Mask Airway information sheet; Intersurgical, Ltd), but it has a harder cuff.…”

The Soft Seal disposable laryngeal mask airway in adults: comparison of two insertion techniques without intra‐oral manipulation

“…First-time insertion success with the SSLM have been reported to range from 62% [13] to 95% [1,14], and overall success from 90% [15] to 100% [1, 16,17]. Insertion times for the SSLM ranges between 20 s [4] and 50 s [13].…”