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

ISRCTN	ISRCTN33426708
DOI	https://doi.org/10.1186/ISRCTN33426708
Secondary identifying numbers	N0226190719

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Iain T Campbell
Scientific

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

Phone	+44 0161 291 5714
Email	iain.campbell@uhsm.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of laryngeal mask airway (LMA) in small airway function in the postoperative period compared with the endotracheal tube (ETT)
Study objectives	To compare the effect of laryngeal mask airway versus end tracheal tube on small airway function in the post operative period.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Small airway function
Intervention	Patients will be randomised to either LMA or ET for anaesthesia.
Intervention type	Procedure/Surgery
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 study start date	05/02/2007
Completion date	05/02/2009

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	80 participants; 2 groups of 40. 40 patients recruited as of August 2008.
Key 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
Key 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
Date of first enrolment	05/02/2007
Date of final enrolment	05/02/2009

University Hospital of South Manchester NHS Foundation Trust

Manchester
M23 9LT
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

30/04/2018: No publications found, study status unverified.
10/03/2016: No publications found, verifying study status with principal investigator