Contact information
Type
Scientific
Primary contact
Dr Mansukh T Popat
ORCID ID
Contact details
Anaesthetics Department
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 01865 221590
mansukh.popat@nda.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176179733
Study information
Scientific title
Acronym
Study hypothesis
The rate of successful insertion during routine clinical anaesthesia is the primary outcome measure for comparison between the two supraglottic airway devices. 'Successful insertion' is defined as the provision of both an unobstructed, patient airway as judged clinically and by the measurement of satisfactory leak pressure. Pressure is needed to ventilate the lungs. Above a certain normal pressure, there is an audible leak of gas from between the patient's larynx and the airway management device. This leak pressure is recorded routinely all anaesthetics. The better the seal of a device at the patient's larynx, the higher the leak pressure.
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
1. Selection of research participants
2. Explanation of research proposal and procedure, including provision of written information sheet and sufficient time for questions
3. Written consent
4. Randomisation to receive either i-gel airway (I-gel group) or LMAu (LMA group)
5. Induction and maintenance of anesthesia in a standard manner
6. Insertion of selected airway device, examining study objectives (as above)
7. After successful insertion, it will be left in place for the maintenance of anaesthesia
8. After the end of the operation the patient will regain consciousness and the device will be removed
9. Routine assessment will be made of sore throat etc, as is normal practice
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measure
Clinically successful placement of the device, ie 'successful insertion' and 'adequate leak pressure'.
Secondary outcome measures
Incidence of complications and post-operative presence of any subjective difficulty or pain with speaking, swallowing, jaw or neck movement, or any alteration to hearing or tongue sensation.
Overall trial start date
18/05/2006
Overall trial end date
18/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. ASA I or II patients (fit and healthy or with minor well-controlled chronic disease)
2. Age 16-70 years
3. Weight 30-120 kg
4. Not pregnant
5. Booked for elective surgery of duration <2 hours
6. Fasted
7. Normal airway assessment
8. Consenting
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300 patients
Participant exclusion criteria
1. Age <16 or >80, or weight <30 or >120kg
2. Pregnancy
3. Emergency surgery
4. Surgery > 2 hours duration
5. Patient not fit (ASA >=III)
6. Patient not starved
7. History of symptomatic reflux disease
8. History of difficult airway mgmt during previous anaesthesia
9. Anticipated difficult airway
10. Previous radiotherapy to head/neck
11. Heavy smokers >20 cigarettes/d
12. Non-consenting
Recruitment start date
18/05/2006
Recruitment end date
18/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics Department
Oxford
OX3 9DU
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
Oxford Radcliffe Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19846406
Publication citations
-
Results
Uppal V, Gangaiah S, Fletcher G, Kinsella J, Randomized crossover comparison between the i-gel and the LMA-Unique in anaesthetized, paralysed adults., Br J Anaesth, 2009, 103, 6, 882-885, doi: 10.1093/bja/aep292.