Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
27/01/2015
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 JE Smith

ORCID ID

Contact details

Anaesthetics
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265105787

Study information

Scientific title

Maintaining and improving skills in fibreoptic intubation

Acronym

Study hypothesis

How frequently do anaesthetists need to perform fibreoptic intubation in order to maintain or improve their endoscopy skills?

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Anaethesia

Intervention

Specifically for research purposes.
45 consultant anaesthetists, based at University Hospital Birmingham, who have performed few or no fibreoptic intubations over the last 3 years, will be studied. Each one will perform 15 fibreoptic orotracheal intubations with a videoendoscope, in elective surgical patients, ASA groups 1 or 11, who need orotracheal intubation as part of their anaesthetic management, under the supervision of an anaesthetist experienced in the technique. Each patient will receive a standard anaesthetic induction and will be treated with isoflurane in 100% oxygen for 2-3 minutes before intubation. The instructor will give
demonstrations, advice, feedback guidance and direct assistance as necessary. The time taken for the fibrescope tip to pass from the mouth to the carina will be noted and recorded. If the oxygen saturation falls below 97% at any time, or the ECG or BP readings fall outside normal limits or if there is any cause for concern about the patient's safety or if the consultant under refresher training is unable to complete the endoscopy within 60 seconds, the instructor will take over and complete the intubation. When the first 15 endoscopies have been performed, learning curves will be constructed for each anaesthetist.

Each anaesthetist will then be randomly allocated to one of three groups. The first group of anaesthetists will perform one intubation every three months, the second group will perform one intubation per month and the third group will perform one intubation per week, again under the supervision of an experienced endoscopist, under the conditions described previously. After one year, each member of each group will then perform a further 15 intubations under the same conditions as before.

The group learning curves will be compiled and compared. The statistical analysis will be performed by Craig Ramsay, Senior Statistician, Health Services Research Unit, University of Aberdeen and will determine which group's skills (if any) have improved, remained stable or deteriorated.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

22/02/2002

Overall trial end date

22/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

The anaesthetists involved will all be consultants based at University Hospital Birmingham. They will be those who have performed few or no fibreoptic intubations over the last 3 years, but who have a strong desire to develop and maintain proficiency in this field.

The patients involved will be elective general, orthopaedic, plastic, gynaecological, ENT or maxillofacial surgical patients, ASA group 1 or 11, aged 16 to 65, who require orotracheal intubation as part of their anaesthetic management and who give informed consent.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

45 consultant anaesthetists

Participant exclusion criteria

Patients with morbid obesity, oesophageal reflux or expected to present difficult intubation will not be included.

Recruitment start date

22/02/2002

Recruitment end date

22/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes