Clinical evaluation of the Portex single use laryngeal mask airway in paediatric anaesthesia: a randomised controlled study with the Intavent "classic" laryngeal mask airway
| ISRCTN | ISRCTN07684370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07684370 |
| Secondary identifying numbers | N0012134103 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/11/2009
- 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 H Glaisyer
Scientific
Scientific
PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
| Phone | +44 (0)20 7405 9200 |
|---|
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 | The primary objective is to establish whether single use Portex laryngeal mask airway performs at least as well as the Intavent 'classic' laryngeal mask airway |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | 1. Single use Portex laryngeal mask 2. Intavent 'classic' laryngeal mask |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Securing a safe airway |
| Secondary outcome measures | Number of insertion attempts, time to satisfactory insertion, ease of insertion, presence of a post op sore throat |
| Overall study start date | 26/09/2003 |
| Completion date | 25/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | Added 18/11/09: 40 |
| Key inclusion criteria | Patients undergoing elective surgery |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 26/09/2003 |
| Date of final enrolment | 25/03/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
PICU
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (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 | 01/02/2005 | Yes | No |
