Clinical evaluation of the Portex single use laryngeal mask airway in paediatric anaesthesia: a randomised controlled study with the Intavent "classic" laryngeal mask airway

ISRCTN ISRCTN07684370
DOI https://doi.org/10.1186/ISRCTN07684370
Secondary identifying numbers N0012134103
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
18/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H Glaisyer
Scientific

PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Phone +44 (0)20 7405 9200

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Anaesthesia
Intervention1. Single use Portex laryngeal mask
2. Intavent 'classic' laryngeal mask
Intervention typeProcedure/Surgery
Primary outcome measureSecuring a safe airway
Secondary outcome measuresNumber of insertion attempts, time to satisfactory insertion, ease of insertion, presence of a post op sore throat
Overall study start date26/09/2003
Completion date25/03/2004

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Target number of participantsAdded 18/11/09: 40
Key inclusion criteriaPatients undergoing elective surgery
Key exclusion criteriaNot provided at time of registration
Date of first enrolment26/09/2003
Date of final enrolment25/03/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

PICU
London
WC1N 3JH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2005 Yes No