Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
06/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tim Cook

ORCID ID

Contact details

Anaesthesia
Royal United Hospital
Bath & North East Somerset Council
Bath
BA1 3NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0212123055

Study information

Scientific title

Acronym

Study hypothesis

Does one of these new single use laryngeal mask airways (LMAs) offer a clinically important benefit over the other?

Ethics approval

Not provided at time of registration

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

LMA Unique™ versus Softseal™ LMA

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Success of airway placement

Secondary outcome measures

1. Manipulations and complications during use
2. Ease of insertion
3. Airway and fibre-optic assessment of airway positioning
4. Complications post-operatively

Overall trial start date

01/05/2003

Overall trial end date

30/09/2004

Reason abandoned

We planned to study 300 patients but interim analysis demonstrated the study should be stopped after 100 patients.

Eligibility

Participant inclusion criteria

1. Patients undergoing elective anaesthetic/surgery
2. Did not receive neuromuscular blockade

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

300 patients planned, study stopped after 100 patients.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/05/2003

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthesia
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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16288620

Publication citations

  1. Results

    Cook TM, Trümpelmann P, Beringer R, Stedeford J, A randomised comparison of the Portex Softseal laryngeal mask airway with the LMA-Unique during anaesthesia., Anaesthesia, 2005, 60, 12, 1218-1225, doi: 10.1111/j.1365-2044.2005.04330.x.

Additional files

Editorial Notes