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 |
| Protocol serial number | N0012134103 |
| Sponsor | Department of Health |
| Funder | Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Securing a safe airway |
| Key secondary outcome measure(s) |
Number of insertion attempts, time to satisfactory insertion, ease of insertion, presence of a post op sore throat |
| Completion date | 25/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
PICU
London
WC1N 3JH
United Kingdom
WC1N 3JH
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 | 01/02/2005 | Yes | No |
