Comparison of the fibreoptic bronchoscope and bougie for tracheal intubation
| ISRCTN | ISRCTN55140217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55140217 |
| Protocol serial number | N0176108553 |
| Sponsor | Department of Health (UK) |
| Funder | Oxford Radcliffe Hospitals NHS Trust |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/07/2009
- 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 Kate Hames
Scientific
Scientific
Anaesthetic Department
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 01865 221590 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | A gum elastic bougie is a semi rigid plastic covered rod which is commonly used to facilitate intubation with an endotracheal tube when difficulty arises as a result of an inadequate view of the larynx with a conventional laryngoscope. This involves 'blindly' placing the bougie in the trachea and guiding a trachael tube over it. Using a flexible fibreoptic bronchoscope has the advantages of allowing continuous visualisation of the airway. This study would compare the two techniques in anaesthetised patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Tracheal intubation |
| Intervention | Randomised trial. Randomisation will be achieved by selecting an envelope containing one of the two methods being studied for guiding the tube into the trachea. The patient will be anaesthetised and therefore unaware of which method is used. It will be impossible to blind the operator (ie the person placing the tube into the trachea) or the assistant (another anaesthetist holding the laryngoscope). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Time from visualisation of the vocal chords to passage of the tube into the trachea |
| Key secondary outcome measure(s) |
The presence or absence of carbon dioxide in the expired gases as a measure of success or failure to pass the tube into the trachea |
| Completion date | 31/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | No less than 20 and no more than 30 patients in each group. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 11/04/2002 |
| Date of final enrolment | 31/07/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Anaesthetic Department
Oxford
OX3 9DU
United Kingdom
OX3 9DU
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 on comparison of single-use bougie with fibrescope | 01/09/2003 | Yes | No | |
| Results article | results on comparison of single-use bougie with multiple-use bougie | 01/09/2003 | Yes | No |
