Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
04/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kim Gupta

ORCID ID

Contact details

Anaesthesia
Royal United Hospital
B&NES
Bath
BA1 3NG
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes