Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/03/2009
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 T Cook

ORCID ID

Contact details

Department of Anaesthetics
Royal United Hospital
Bath & North East Somerset Council
Bath
BA1 3NG
United Kingdom

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes