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 |
| Protocol serial number | N0212123055 |
| Sponsor | Department of Health |
| Funder | Royal United Hospital Bath NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Success of airway placement |
| Key secondary outcome measure(s) |
1. Manipulations and complications during use |
| 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 sample size at registration | 100 |
| 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
- United Kingdom
- England
Study participating centre
Anaesthesia
Bath
BA1 3NG
United Kingdom
BA1 3NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
