| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN41353942 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0212123055 |
| Public title | Trial to compare the 'Unique' laryngeal mask airway with the 'Softseal' laryngeal mask airway for airway management |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Surgery: Anaesthesia |
| Study hypothesis | Does one of these new single use LMAs offer a clinically important benefit over the other? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients undergoing elective anaesthetic/surgery |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/05/2003 |
| Anticipated end date | 30/09/2004 |
| Status of trial | Completed |
| Target number of participants | 300 patients planned, study stopped after 100 patients. |
| Interventions | Randomised controlled trial, qualitative |
| Primary outcome measure(s) | Primary outcome was success of airway placement. Secondary outcomes included manipulations and complications during use, ease of insertion, airway and fibreoptic assessment of airway positioning, and complications post-operatively. |
| Secondary outcome measure(s) | See Primary outcome measures |
| Sources of funding | Royal United Hospital Bath NHS Trust
Not available
|
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Tim Cook |
| Contact details | Anaesthesia
Royal United Hospital
B&NES
Bath
United Kingdom
BA1 3NG |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN41353942 |
| Date last extracted from ISRCTN register | 17/04/2008 |
