Maintaining and improving skills in fibreoptic intubation
| ISRCTN | ISRCTN35203543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35203543 |
| Secondary identifying numbers | N0265105787 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 27/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr JE Smith
Scientific
Scientific
Anaesthetics
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Maintaining and improving skills in fibreoptic intubation |
| Study objectives | How frequently do anaesthetists need to perform fibreoptic intubation in order to maintain or improve their endoscopy skills? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 22/02/2002 |
| Completion date | 22/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 45 consultant anaesthetists |
| Key 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. |
| Key exclusion criteria | Patients with morbid obesity, oesophageal reflux or expected to present difficult intubation will not be included. |
| Date of first enrolment | 22/02/2002 |
| Date of final enrolment | 22/02/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
University Hospital Birmingham NHS Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
