Comparison of the disposable reinforced laryngeal mask airway (LMA) and the original reusable reinforced LMA

ISRCTN	ISRCTN35126835
DOI	https://doi.org/10.1186/ISRCTN35126835
Protocol serial number	N0263139737
Sponsor	Department of Health
Funder	University College London Hospitals 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 V Mitchell
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Do disposable reinforced LMAs perform as well as the reusable reinforced LMAs in clinical practice?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	1. Disposable reinforced laryngeal mask 2. Original reusable reinforced laryngeal mask airway
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Ease of insertion, chest inflation, intraoperative performance, airway maintenance in recovery, trauma or atraumatic insertion and removal.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	100 patients from Anaesthetics
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2004
Date of final enrolment	01/08/2006

Anaesthetics

London
WC1 9LAZ
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	01/12/2007		Yes	No