Comparison of the fibreoptic bronchoscope and bougie for tracheal intubation

ISRCTN ISRCTN55140217
DOI https://doi.org/10.1186/ISRCTN55140217
Secondary identifying numbers N0176108553
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

Anaesthetic Department
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Phone +44 01865 221590

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesA 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) studiedSurgery: Tracheal intubation
InterventionRandomised 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 typeProcedure/Surgery
Primary outcome measureTime from visualisation of the vocal chords to passage of the tube into the trachea
Secondary outcome measuresThe presence or absence of carbon dioxide in the expired gases as a measure of success or failure to pass the tube into the trachea
Overall study start date11/04/2002
Completion date31/07/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteriaNo less than 20 and no more than 30 patients in each group.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment11/04/2002
Date of final enrolment31/07/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Anaesthetic Department
Oxford
OX3 9DU
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Oxford Radcliffe Hospitals NHS Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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