Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012134103
Study information
Scientific title
Acronym
Study hypothesis
The primary objective is to establish whether single use Portex laryngeal mask airway performs at least as well as the Intavent 'classic' laryngeal mask airway
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
1. Single use Portex laryngeal mask
2. Intavent 'classic' laryngeal mask
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Securing a safe airway
Secondary outcome measures
Number of insertion attempts, time to satisfactory insertion, ease of insertion, presence of a post op sore throat
Overall trial start date
26/09/2003
Overall trial end date
25/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing elective surgery
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Added 18/11/09: 40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
26/09/2003
Recruitment end date
25/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
PICU
London
WC1N 3JH
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
Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (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/15675926
Publication citations
-
Results
Glaisyer HR, Yule C, The Portex 'Soft Seal' single use laryngeal mask -- a preliminary study in pediatric anesthesia., Paediatr Anaesth, 2005, 15, 2, 110-114, doi: 10.1111/j.1460-9592.2005.01452.x.