Comparison of three methods to facilitate orotracheal fibreoptic intubation
| ISRCTN | ISRCTN02283165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02283165 |
| Secondary identifying numbers | N0265109342 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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
| Phone | +44 (0)121 627 1627 |
|---|---|
| none@example.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 | Comparison of three methods to facilitate orotracheal fibreoptic intubation |
| Study objectives | The object of the study is to determine whether laryngoscope-assisted fibreoptic intubation results in better airway clearance and a shorter intubation time than other methods of fibreoptic intubation, and also to determine if laryngoscope-assisted fibreoptic intubation reduces the cardiovascular response to intubation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Intubation |
| Intervention | The investigators will carry out the normal bedside assessment of the airways of patients who require orotracheal intubation as part of their anaesthetic management. If a patient presents one of the criteria for difficult intubation {viz Mallampati class III or IV, thyromental distance <6.5 cm, interincisor distance between 3 and 5 cm, protruding upper teeth, small mouth or mandible or reduced neck mobility) he or she will be invited to take part in the trial. He or she will then be scheduled for an orotracheal fibreoptic intubation, since this is the most appropriate treatment when there is an increased risk of difficult intubation. A normal general anaesthetic will be given comprising pre-oxygenation with 100% oxygen, induction with fentanyl (l mcg/kg) and propofol (2.5 mg/kg) and ventilation of the lungs with oxygen, nitrous oxide and isoflurane (0.5% end-tidal) with the aid of a Guedel airway. After confirmation of easy ventilation of the lungs, atracurium (0.5 mg/kg) will be given and mask ventilation will be continued until muscular relaxation is complete. Immediately before intubation, patients will be randomised to have one of three manoeuvres to facilitate fibreoptic intubation: 1. Jaw thrust while keeping the mouth open together with lingual traction applied using Duval's forceps. 2. The insertion of a Berman airway into the mouth. 3. The insertion of a Macintosh size 3 laryngoscope into the mouth, placing its tip into the vallecula and lifting the tongue anteriorly. The following timings will be made on every patient: 1. Endoscopy time - the time for the fibrescope to pass from the lips to the carina and 2. Intubation time - the time from the fibrescope passing between the lips to the detection of carbon dioxide by the gas analyser. Heart rate, non-invasive blood pressure and pulse oximetry will be measured and recorded at 1 min intervals throughout the procedure. After intubation, the patient's surgery will commence. The patients will be reviewed in the Recovery area and on the first postoperative day, on the general ward. The presence of pharyngeal or lingual discomfort will be assessed and graded as mild, moderate or severe. If the oxygen saturation falls below 97% at any time, or the electrocardiogram (ECG) or blood pressure (BP) readings fall outside normal limits, or if the endoscopy is not completed with 60 s, or if there is any concern for the patient's safety, the study period will end and appropriate action will be taken to treat the patient and facilitate endotracheal intubation. |
| 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 | 07/05/2002 |
| Completion date | 07/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | 45 Patients will be recruited to the study. 1. Aged 16-65 2. American Society of Anesthesiologists (ASA) 1 or 2 3. Undergoing elective procedures requiring orotracheal intubation 4. Presenting one clinical sign predicting difficult intubation 5. Giving informed written consent. |
| Key exclusion criteria | 1. Cardiovascular or cerebrovascular disease 2. Diabetes 3. Autonomic neuropathy 4. Patients taking vasoactive drugs 5. Oesophageal reflux 6. Morbid obesity (Body Mass Index [BMI] >35) 7. Fixed flexion deformity of the spine 8. Patients known to be difficult intubations 9. Patients demonstrating multiple clinical signs which in combination strongly predict difficult intubation |
| Date of first enrolment | 07/05/2002 |
| Date of final enrolment | 07/03/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | comparison of two methods of fibrescope-guided tracheal intubation | 01/05/1991 | Yes | No |
Editorial Notes
08/11/2022: Internal review.
