Trial to compare the Airway Management Device (AMD) with the Classic Laryngeal Mask Airway™
ISRCTN | ISRCTN00263336 |
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DOI | https://doi.org/10.1186/ISRCTN00263336 |
Secondary identifying numbers | N0212075199 |
- 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 |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | To compare the performance of the Airway Management Device (AMD) with the Classic Laryngeal Mask Airway™ during insertion, maintenance and removal in anaesthetised adult patients. |
Ethics approval(s) | Research Ethics Committee of Royal United Hospital Bath approved the study |
Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
Intervention | Airway Management Device versus the Classic Laryngeal Mask Airway™ during surgery in anaesthetised patients. |
Intervention type | Device |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | Success of airway placement |
Secondary outcome measures | 1. Time to achieve an airway 2. Airway manipulations required 3. Complications during use 4. Fibre-optic assessment of airway positioning |
Overall study start date | 01/09/2000 |
Completion date | 30/04/2003 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 100 |
Key inclusion criteria | Adult patients undergoing surgery requiring general anaesthetic which would normally involve using LMA |
Key exclusion criteria | 1. Any pathology of the neck or the upper respiratory or upper alimentary tract 2. At risk of pulmonary aspiration of gastric contents 3. Weight less than 50 kg or greater than 100 kg |
Date of first enrolment | 01/09/2000 |
Date of final enrolment | 30/04/2003 |
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 |
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Funders
Funder type
Government
Royal United Hospital Bath NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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 | 01/11/2003 | Yes | No |