Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
10/03/2016
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

Prof Iain T Campbell

ORCID ID

Contact details

University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 0161 291 5714
iain.campbell@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226190719

Study information

Scientific title

Effect of laryngeal mask airway (LMA) in small airway function in the postoperative period compared with the endotracheal tube (ETT)

Acronym

Study hypothesis

To compare the effect of laryngeal mask airway versus end tracheal tube on small airway function in the post operative period.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Small airway function

Intervention

Patients will be randomised to either LMA or ET for anaesthesia.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Changes in airway resistance in the lung.

Secondary outcome measures

If there are marked differences it will add a new dimension to the choice of airway device used in patients with constrictive/obstructive airways disease.

Overall trial start date

05/02/2007

Overall trial end date

05/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. ASA Grades 1 or 2 (ie healthy patients of patients with well controlled chronic conditions) for elective surgery expected to last >30mins, on peripheral or body surfaces. We expect this would mean mainly orthopaedic or plastic surgery patients but could include vascular (varicose veins)
2. Smokers and non-smokers
3. BMI <30
4. Patients consenting to the research
5. No history of gastric reflux

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80 participants; 2 groups of 40. 40 patients recruited as of August 2008.

Participant exclusion criteria

1. ASA 3 or higher
2. BMI >30
3. Patients suffering with gastro-oesophageal reflux
4. Patients unable to consent to the research or those who refuse to participate

Recruitment start date

05/02/2007

Recruitment end date

05/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
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

University Hospital of South Manchester NHS Foundation Trust (UK), NHS R&D Support Funding

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

10/03/2016: No publications found, verifying study status with principal investigator