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

ISRCTN	ISRCTN00263336
DOI	https://doi.org/10.1186/ISRCTN00263336
Protocol serial number	N0212075199
Sponsor	Department of Health (UK)
Funder	Royal United Hospital Bath NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr T Cook
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Research Ethics Committee of Royal United Hospital Bath approved the study
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	Airway Management Device versus the Classic Laryngeal Mask Airway™ during surgery in anaesthetised patients.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Success of airway placement
Key secondary outcome measure(s)	1. Time to achieve an airway 2. Airway manipulations required 3. Complications during use 4. Fibre-optic assessment of airway positioning
Completion date	30/04/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	Adult patients undergoing surgery requiring general anaesthetic which would normally involve using LMA
Key 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
Date of first enrolment	01/09/2000
Date of final enrolment	30/04/2003

Department of Anaesthetics

Bath
BA1 3NG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2003		Yes	No