Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H Glaisyer

ORCID ID

Contact details

PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
+44 (0)20 7405 9200

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15675926

Publication citations

  1. 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.

Additional files

Editorial Notes