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