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
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