Trial to compare the Airway Management Device (AMD) with the Classic Laryngeal Mask Airway™

ISRCTN ISRCTN00263336
DOI https://doi.org/10.1186/ISRCTN00263336
Secondary identifying numbers N0212075199
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
06/03/2009
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 T Cook
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Research Ethics Committee of Royal United Hospital Bath approved the study
Health condition(s) or problem(s) studiedSurgery: Anaesthesia
InterventionAirway Management Device versus the Classic Laryngeal Mask Airway™ during surgery in anaesthetised patients.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureSuccess of airway placement
Secondary outcome measures1. Time to achieve an airway
2. Airway manipulations required
3. Complications during use
4. Fibre-optic assessment of airway positioning
Overall study start date01/09/2000
Completion date30/04/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteriaAdult patients undergoing surgery requiring general anaesthetic which would normally involve using LMA
Key exclusion criteria1. 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
Date of first enrolment01/09/2000
Date of final enrolment30/04/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthetics
Bath
BA1 3NG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Royal United Hospital Bath NHS Trust (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 01/11/2003 Yes No