A randomised crossover comparison of the Cobra Perilaryngeal Airway (CobraPLA®) and Classic Laryngeal Mask Airway™ during anaesthesia in ventilated patients

ISRCTN	ISRCTN94330556
DOI	https://doi.org/10.1186/ISRCTN94330556
Secondary identifying numbers	N0212140555

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Tim Cook
Scientific

Anaesthesia
Royal United Hospital
Bath & North East Somerset Council
Bath
BA1 3NG
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Does the CobraPLA® perform as well as the Classic Laryngeal Mask Airway™ during anaesthesia?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	CobraPLA® and Classic Laryngeal Mask Airway™
Intervention type	Procedure/Surgery
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2004
Completion date	13/08/2004
Reason abandoned (if study stopped)	Terminated due to two cases of pulmonary aspiration during this and a related study which lead to the decision that the risk to the participants of continuing the study outweighed the potential benefits.

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	8 patients recruited - aiming for 32
Key inclusion criteria	1. Patients undergoing anaesthesia with ventilation of the lungs 2. Patients have been included if they were undergoing elective anaesthesia for surgery
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2004
Date of final enrolment	13/08/2004

Anaesthesia

Bath
BA1 3NG
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal United Hospital Bath NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2005		Yes	No