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

Anaesthetics
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Phone +44 (0)121 627 1627
Email none@example.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleComparison of three methods to facilitate orotracheal fibreoptic intubation
Study objectivesThe 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) studiedSurgery: Intubation
InterventionThe 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 typeProcedure/Surgery
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date07/05/2002
Completion date07/03/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants45
Key inclusion criteria45 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 criteria1. 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 enrolment07/05/2002
Date of final enrolment07/03/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Anaesthetics
Birmingham
B29 6JD
United Kingdom

Sponsor information

Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.