Trial to compare the Laryngeal Tube Sonda® with the ProSeal® Laryngeal Mask Airway
| ISRCTN | ISRCTN69551962 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69551962 |
| Protocol serial number | N0212120671 |
| Sponsor | Department of Health (UK) |
| Funder | Royal United Hospital Bath NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 06/03/2009
- 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 T Cook
Scientific
Scientific
Department of Anaesthetics
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 Laryngeal Tube Sonda® perform as well as the ProSeal® Laryngeal Mask Airway? |
| Ethics approval(s) | The local research ethics committee approved the study |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | ProSeal® Laryngeal Mask Airway versus Laryngeal Tube Sonda® |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Added 06/03/2009: |
| Key secondary outcome measure(s) |
Added 06/03/2009: |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 32 |
| Key inclusion criteria | Added 06/03/2009: 1. American Society of Anaesthesiology (ASA) grade I - III 2. Undergoing elective surgery in the supine or lithotomy position 3. Use of neuromuscular blockade and LMA is appropriate |
| Key exclusion criteria | Added 06/03/2009: 1. Any pathology of the neck, upper respiratory tract or upper alimentary tract 2. At increased risk of pulmonary aspiration of gastric contents 3. Weighed less than 50 kg or had a height less than 155 cm |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthetics
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 |
