A randomised crossover comparison of the Cobra Perilaryngeal Airway (CobraPLA®) and Classic Laryngeal Mask Airway™ during anaesthesia in ventilated patients
| ISRCTN | ISRCTN94330556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94330556 |
| Protocol serial number | N0212140555 |
| 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 the CobraPLA® perform as well as the Classic Laryngeal Mask Airway™ during anaesthesia? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | CobraPLA® and Classic Laryngeal Mask Airway™ |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 13/08/2004 |
| Reason abandoned (if study stopped) | Terminated due to two cases of pulmonary aspiration during this and a related study which lead to the decision that the risk to the participants of continuing the study outweighed the potential benefits. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 8 |
| Key inclusion criteria | 1. Patients undergoing anaesthesia with ventilation of the lungs 2. Patients have been included if they were undergoing elective anaesthesia for surgery |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 13/08/2004 |
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 | 01/08/2005 | Yes | No |
