A randomised comparison of two techniques for inflation of the Classic Laryngeal Mask Airway (CLMA) during anaesthesia

ISRCTN	ISRCTN33777350
DOI	https://doi.org/10.1186/ISRCTN33777350
Secondary identifying numbers	N0212157341

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 Kim Gupta
Scientific

Anaesthesia
Royal United Hospital
B&NES
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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised comparison of two techniques for inflation of the Classic Laryngeal Mask Airway (CLMA) during anaesthesia
Study objectives	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(s)	Bath Research Ethics Committee, 24/03/2005, ref: 05/Q2001/31
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	Technique 1 vs technique 2 for inflation of the Classic Laryngeal Mask Airway (CLMA) during anaesthesia
Intervention type	Procedure/Surgery
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 study start date	24/02/2005
Completion date	01/07/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Aiming for 130 patients
Key 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.
Key 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
Date of first enrolment	24/02/2005
Date of final enrolment	01/07/2008

Royal United Hospital

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