Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
12/05/2009
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 V Mitchell

ORCID ID

Contact details

Anaesthetics
Department of Anaesthetics
Room 103
1st Floor Crosspiece
Middlesex Hospital
London
WC1 9LAZ
United Kingdom

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

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

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

  1. 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.

Additional files

Editorial Notes