Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0212120671
Study information
Scientific title
Acronym
Study hypothesis
Does the Laryngeal Tube Sonda® perform as well as the ProSeal® Laryngeal Mask Airway?
Ethics approval
The local research ethics committee 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
ProSeal® Laryngeal Mask Airway versus Laryngeal Tube Sonda®
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Added 06/03/2009:
Airway seal pressure
Secondary outcome measures
Added 06/03/2009:
1. Insertion success and time
2. Manipulations required
3. Ventilation quality
4. Peak and plateau airway pressures
5. Ability to pass a gastric tube
6. Fibre-optic laryngeal view
Overall trial start date
01/03/2003
Overall trial end date
01/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Added 06/03/2009:
1. American Society of Anaesthesiology (ASA) grade I - III
2. Undergoing elective surgery in the supine or lithotomy position
3. Use of neuromuscular blockade and LMA is appropriate
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Added 06/03/2009: 32 patients
Participant exclusion criteria
Added 06/03/2009:
1. Any pathology of the neck, upper respiratory tract or upper alimentary tract
2. At increased risk of pulmonary aspiration of gastric contents
3. Weighed less than 50 kg or had a height less than 155 cm
Recruitment start date
01/03/2003
Recruitment end date
01/06/2003
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
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15923264
Publication citations
-
Results
Cook TM, Cranshaw J, Randomized crossover comparison of ProSeal Laryngeal Mask Airway with Laryngeal Tube Sonda during anaesthesia with controlled ventilation., Br J Anaesth, 2005, 95, 2, 261-266, doi: 10.1093/bja/aei167.