Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/03/2009
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 T Cook

ORCID ID

Contact details

Department of Anaesthetics
Royal United Hospital
Bath & North East Somerset Council
Bath
BA1 3NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0212075199

Study information

Scientific title

Acronym

Study hypothesis

To compare the performance of the Airway Management Device (AMD) with the Classic Laryngeal Mask Airway™ during insertion, maintenance and removal in anaesthetised adult patients.

Ethics approval

Research Ethics Committee of Royal United Hospital Bath approved the study

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

Airway Management Device versus the Classic Laryngeal Mask Airway™ during surgery in anaesthetised patients.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

Success of airway placement

Secondary outcome measures

1. Time to achieve an airway
2. Airway manipulations required
3. Complications during use
4. Fibre-optic assessment of airway positioning

Overall trial start date

01/09/2000

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients undergoing surgery requiring general anaesthetic which would normally involve using LMA

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Any pathology of the neck or the upper respiratory or upper alimentary tract
2. At risk of pulmonary aspiration of gastric contents
3. Weight less than 50 kg or greater than 100 kg

Recruitment start date

01/09/2000

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthetics
Bath
BA1 3NG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Royal United Hospital Bath 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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14570789

Publication citations

  1. Results

    Cook TM, Porter MV, Randomized comparison of the classic Laryngeal Mask Airway with the Airway Management Device during anaesthesia., Br J Anaesth, 2003, 91, 5, 672-677.

Additional files

Editorial Notes