Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263139737
Study information
Scientific title
Acronym
Study hypothesis
Do disposable reinforced LMAs perform as well as the reusable reinforced LMAs in clinical practice?
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Anaesthesia
Intervention
1. Disposable reinforced laryngeal mask
2. Original reusable reinforced laryngeal mask airway
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Ease of insertion, chest inflation, intraoperative performance, airway maintenance in recovery, trauma or atraumatic insertion and removal.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2004
Overall trial end date
01/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
100 patients from Anaesthetics
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
100 children
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2004
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics
London
WC1 9LAZ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University College London Hospitals 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
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17991266
Publication citations
-
Results
Flynn P, Ahmed FB, Mitchell V, Patel A, Clarke S, A randomised comparison of the single use LMA Flexible with the reusable LMA Flexible in paediatric dental day-case patients., Anaesthesia, 2007, 62, 12, 1281-1284, doi: 10.1111/j.1365-2044.2007.05234.x.