Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176108553
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Time from visualisation of the vocal chords to passage of the tube into the trachea
Secondary outcome measures
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
Overall trial start date
11/04/2002
Overall trial end date
31/07/2002
Reason abandoned
Eligibility
Participant inclusion criteria
No less than 20 and no more than 30 patients in each group.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
11/04/2002
Recruitment end date
31/07/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetic Department
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Oxford Radcliffe Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2003 results on comparison of single-use bougie with fibrescope in http://www.ncbi.nlm.nih.gov/pubmed/12911355
2. 2003 results on comparison of single-use bougie with multiple-use bougie in http://www.ncbi.nlm.nih.gov/pubmed/12911356
Publication citations
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Hames KC, Pandit JJ, Marfin AG, Popat MT, Yentis SM, Use of the bougie in simulated difficult intubation. 1. Comparison of the single-use bougie with the fibrescope., Anaesthesia, 2003, 58, 9, 846-851.
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Marfin AG, Pandit JJ, Hames KC, Popat MT, Yentis SM, Use of the bougie in simulated difficult intubation. 2. Comparison of single-use bougie with multiple-use bougie., Anaesthesia, 2003, 58, 9, 852-855.