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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list