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
Scientific
Anaesthetics Department
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 01865 221590 |
|---|---|
| mansukh.popat@nda.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 18/05/2006 |
| Completion date | 18/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/05/2006 |
| Date of final enrolment | 18/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics Department
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2009 | Yes | No |
