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
Protocol serial number	N0212157341
Sponsor	Department of Health
Funder	Royal United Hospital Bath NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Added 22/07/2008: 1. Airway seal pressure 2. Composite measures of adequacy of airway device placement
Key secondary outcome measure(s)	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
Completion date	01/07/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	130
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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes