Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0212140555
Study information
Scientific title
Acronym
Study hypothesis
Does the CobraPLA® perform as well as the Classic Laryngeal Mask Airway™ during anaesthesia?
Ethics approval
Not provided at time of registration
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
CobraPLA® and Classic Laryngeal Mask Airway™
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2004
Overall trial end date
13/08/2004
Reason abandoned
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.
Eligibility
Participant inclusion criteria
1. Patients undergoing anaesthesia with ventilation of the lungs
2. Patients have been included if they were undergoing elective anaesthesia for surgery
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
8 patients recruited - aiming for 32
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2004
Recruitment end date
13/08/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthesia
Bath
BA1 3NG
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
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
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16029228
Publication citations
-
Results
Cook TM, Lowe JM, An evaluation of the Cobra Perilaryngeal Airway: study halted after two cases of pulmonary aspiration., Anaesthesia, 2005, 60, 8, 791-796, doi: 10.1111/j.1365-2044.2005.04261.x.