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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14570789
Publication citations
-
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.