Trial to compare the Laryngeal Tube Sonda® with the ProSeal® Laryngeal Mask Airway
| ISRCTN | ISRCTN69551962 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69551962 |
| Secondary identifying numbers | N0212120671 |
- 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
| 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 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 | Added 06/03/2009: Airway seal pressure |
| Secondary outcome measures | Added 06/03/2009: 1. Insertion success and time 2. Manipulations required 3. Ventilation quality 4. Peak and plateau airway pressures 5. Ability to pass a gastric tube 6. Fibre-optic laryngeal view |
| Overall study start date | 01/03/2003 |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Added 06/03/2009: 32 patients |
| 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
- England
- United Kingdom
Study participating centre
Department of Anaesthetics
Bath
BA1 3NG
United Kingdom
BA1 3NG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
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 | 01/08/2005 | Yes | No |
