Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate Hames

ORCID ID

Contact details

Anaesthetic Department
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 01865 221590

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes