Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0212157341
Study information
Scientific title
A randomised comparison of two techniques for inflation of the Classic Laryngeal Mask Airway (CLMA) during anaesthesia
Acronym
Study hypothesis
Is there any difference in performance of the Laryngeal Mask Airway (LMA) when using either of the 2 techniques of cuff inflation described?
Ethics approval
Bath Research Ethics Committee, 24/03/2005, ref: 05/Q2001/31
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Anaesthesia
Intervention
Technique 1 vs technique 2 for inflation of the Classic Laryngeal Mask Airway (CLMA) during anaesthesia
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Added 22/07/2008:
1. Airway seal pressure
2. Composite measures of adequacy of airway device placement
Secondary outcome measures
Added 22/07/2008:
1. Composite measures to assess functional adequacy of airway device
2. Volume of air in LMA cuff at on removal
3. Initial cuff pressure after syringe inflation
4. Composite measures of pharyngeal trauma
Overall trial start date
24/02/2005
Overall trial end date
01/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients presenting to RUH for day case and minor in-patient operations who meet the inclusion criteria for the trial and who are to be anaesthetised by any of the investigators.
All patients who are having an anaesthetic where the CLMA would be expected to be the airway used are suitable to be recruited. We will study 130 adult patients (American Society of Anaesthesiologists physical status 1 - 3 age >16 years) undergoing non-emergency surgery in the supine or lithotomy position under general anaesthesia with spontaneous respiration during maintenance of anaesthesia.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Aiming for 130 patients
Participant exclusion criteria
1. Patients will not be studied if they have any pathology of the neck
2. At risk of pulmonary aspiration of gastric contents
3. Unable to understand the study or give informed consent to take part
4. We will not study patients weighing less than 35 kg or greater than 120 kg
Recruitment start date
24/02/2005
Recruitment end date
01/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal United Hospital
Bath
BA1 3NG
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)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
Basic results (scientific)
Publication list