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Trial to compare the 'Unique' laryngeal mask airway with the 'Softseal' laryngeal mask airway for airway management
ISRCTN ISRCTN41353942
ClinicalTrials.gov identifier
Public title Trial to compare the 'Unique' laryngeal mask airway with the 'Softseal' laryngeal mask airway for airway management
Scientific title
Acronym N/A
Serial number at source N0212123055
Study hypothesis Does one of these new single use LMAs offer a clinically important benefit over the other?
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Surgery: Anaesthesia
Participants - inclusion criteria Patients undergoing elective anaesthetic/surgery
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/05/2003
Anticipated end date 30/09/2004
Status of trial Completed
Patient information material
Target number of participants 300 patients planned, study stopped after 100 patients.
Interventions Randomised controlled trial, qualitative
Primary outcome measure(s) 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 post-operatively.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Royal United Hospital Bath NHS Trust
Not available
Trial website
Publications
Contact name Dr  Tim  Cook
  Address Anaesthesia
Royal United Hospital
B&NES
  City/town Bath
  Zip/Postcode BA1 3NG
  Country United Kingdom
Sponsor Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
  Address The Department of Health, Richmond House, 79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2005
Last edited 03/10/2005
Date ISRCTN assigned 30/09/2005
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