A prospective randomised comparison of I-gel and LMA-unique Supraglottic Airway Devices for use during Clinical Anaesthesia

ISRCTN ISRCTN39871601
DOI https://doi.org/10.1186/ISRCTN39871601
Secondary identifying numbers N0176179733
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
28/10/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mansukh T Popat
Scientific

Anaesthetics Department
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Phone +44 01865 221590
Email mansukh.popat@nda.ox.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Anaesthesia
Intervention1. 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measureClinically successful placement of the device, ie 'successful insertion' and 'adequate leak pressure'.
Secondary outcome measuresIncidence 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 study start date18/05/2006
Completion date18/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300 patients
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/05/2006
Date of final enrolment18/05/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Anaesthetics Department
Oxford
OX3 9DU
United Kingdom

Sponsor information

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

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Oxford Radcliffe Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2009 Yes No