Trial to compare the laryngeal mask airway (LMA) Unique™ with the Softseal™ LMA for airway management
| ISRCTN | ISRCTN41353942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41353942 |
| Secondary identifying numbers | N0212123055 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 06/03/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Contact information
Dr Tim Cook
Scientific
Scientific
Anaesthesia
Royal United Hospital
Bath & North East Somerset Council
Bath
BA1 3NG
United Kingdom
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 | Does one of these new single use laryngeal mask airways (LMAs) offer a clinically important benefit over the other? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | LMA Unique™ versus Softseal™ LMA |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Success of airway placement |
| Secondary outcome measures | 1. Manipulations and complications during use 2. Ease of insertion 3. Airway and fibre-optic assessment of airway positioning 4. Complications post-operatively |
| Overall study start date | 01/05/2003 |
| Completion date | 30/09/2004 |
| Reason abandoned (if study stopped) | We planned to study 300 patients but interim analysis demonstrated the study should be stopped after 100 patients. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 300 patients planned, study stopped after 100 patients. |
| Key inclusion criteria | 1. Patients undergoing elective anaesthetic/surgery 2. Did not receive neuromuscular blockade |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthesia
Bath
BA1 3NG
United Kingdom
BA1 3NG
United Kingdom
Sponsor information
Department of Health
Government
Government
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
Royal United Hospital Bath NHS Trust (UK)
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 | 01/12/2005 | Yes | No |
