Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0212123055
Study information
Scientific title
Acronym
Study hypothesis
Does one of these new single use laryngeal mask airways (LMAs) offer a clinically important benefit over the other?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Anaesthesia
Intervention
LMA Unique™ versus Softseal™ LMA
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Success of airway placement
Secondary outcome measures
1. Manipulations and complications during use
2. Ease of insertion
3. Airway and fibre-optic assessment of airway positioning
4. Complications post-operatively
Overall trial start date
01/05/2003
Overall trial end date
30/09/2004
Reason abandoned (if study stopped)
We planned to study 300 patients but interim analysis demonstrated the study should be stopped after 100 patients.
Eligibility
Participant inclusion criteria
1. Patients undergoing elective anaesthetic/surgery
2. Did not receive neuromuscular blockade
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
300 patients planned, study stopped after 100 patients.
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/05/2003
Recruitment end date
30/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthesia
Bath
BA1 3NG
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal United Hospital Bath NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16288620
Publication citations
-
Results
Cook TM, Trümpelmann P, Beringer R, Stedeford J, A randomised comparison of the Portex Softseal laryngeal mask airway with the LMA-Unique during anaesthesia., Anaesthesia, 2005, 60, 12, 1218-1225, doi: 10.1111/j.1365-2044.2005.04330.x.