Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265109342
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
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: 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
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/05/2002
Overall trial end date
07/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant 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
Recruitment start date
07/05/2002
Recruitment end date
07/03/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
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
Basic results (scientific)
Publication list
1. 1991 comparison of two methods of fibrescope-guided tracheal intubation in http://www.ncbi.nlm.nih.gov/pubmed/2031813
Publication citations
-
Smith JE, Mackenzie AA, Scott-Knight VC, Comparison of two methods of fibrescope-guided tracheal intubation., Br J Anaesth, 1991, 66, 5, 546-550.