Document Detail

A randomised comparison of the Portex Softseal laryngeal mask airway with the LMA-Unique during anaesthesia.
MedLine Citation:
PMID:  16288620     Owner:  NLM     Status:  MEDLINE    
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 cmH(2)O, 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.
T M Cook; P Trümpelmann; R Beringer; J Stedeford
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Anaesthesia     Volume:  60     ISSN:  0003-2409     ISO Abbreviation:  Anaesthesia     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2005-11-18     Completed Date:  2005-12-19     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370524     Medline TA:  Anaesthesia     Country:  England    
Other Details:
Languages:  eng     Pagination:  1218-25     Citation Subset:  AIM; IM    
Royal United Hospital, Combe Park, Bath, UK.
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MeSH Terms
Airway Obstruction / etiology
Anesthesia, General*
Device Removal
Equipment Design
Intubation, Intratracheal / methods
Laryngeal Masks* / adverse effects
Middle Aged
Pharyngitis / etiology
Postoperative Complications
Treatment Failure
Comment In:
Anaesthesia. 2006 Apr;61(4):402-3; author reply 403-4   [PMID:  16548964 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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