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Randomized Controlled Trial Comparative Study Clinical Trial
Randomised, crossover comparison of the single-use SoftSeal and the LMA Unique laryngeal mask airways.
- M J Paech, O Tweedie, K Stannard, M Hepp, P Dodd, H Daly, E-J Bennett, A Millard, and D A Doherty.
- Department of Anaesthesia and Pain Medicine, School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia. michael.paech@health.wa.gov.au
- Anaesthesia. 2005 Apr 1;60(4):354-9.
AbstractWe performed a randomised, crossover, single-blind trial among 168 patients, to compare the single-use SoftSeal and LMA Unique laryngeal mask airways in spontaneously breathing adults. Size-3 and -4 laryngeal mask airways, inserted by experienced anaesthetists, performed equivalently for successful first-time placement (148 (91%) vs 155 (96%) for the SoftSeal and LMA Unique, respectively). The SoftSeal was more often rated as difficult to insert (27 (17%) vs 4 (3%); p < 0.001) and was more likely to show evidence of mucosal trauma after the first insertion (14 (10%) vs 5 (4%); OR 1.3 (95% CI 1.3-11.3); p < 0.05). The fibreoptic view of the larynx was better through the SoftSeal (vocal cords not visible in 27 (17%) vs 44 (27%); p < 0.05) and it more frequently provided a ventilation seal at 20 cmH(2)O (93 (59%) vs 62 (39%); OR 2.15 (CI 1.44-3.21); p < 0.001). In contrast to the LMA Unique(trade mark), its cuff pressure did not increase during nitrous oxide anaesthesia (median (IQR [range]) decrease 3 (- 20-23 [-40-94]) cmH(2)O vs increase of 16 (-2-39 [-54-112]) cmH(2)O; p < 0.01). Both devices were equivalent for the success of first-time insertion and performed satisfactorily clinically. There were some performance differences, but either appears suitable for airway management in spontaneously breathing patients.
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