Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000171213
Ethics application status
Not yet submitted
Date submitted
29/12/2008
Date registered
9/04/2009
Date last updated
9/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of tracheal intubation in the simulated unstable cervical spine: McGrath videolaryngoscope versus Macintosh laryngoscope
Scientific title
In patients with a simulated unstable cervical spine, does laryngoscopy with a McGrath videolaryngoscope versus a Macintosh laryngoscope result in faster intubation, better laryngoscopic view and reduced intubation difficulty?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation in the setting of potential cervical spine instability 4162 0
Condition category
Condition code
Anaesthesiology 4598 4598 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intubation with a McGrath videolaryngoscope. Intubation involves passing an endotracheal tube into the trachea to enable ventilation during surgery. Evidence suggests that the McGrath videolaryngoscope provides an improved view of the larynx to enable safe passage of the tracheal tube. Duration of laryngoscope will be approximately 30-60 secs. Intubation will take place after induction of anaesthesia.
Intervention code [1] 4086 0
Treatment: Devices
Comparator / control treatment
Conventional direct laryngoscopy with a Macintosh laryngoscope. A Macintosh laryngoscope is a metal instrument with a light which enables retraction of the soft tissues of the oropharynx in order to expose the larynx as described above. Duration of the procedure will be 30-60 secs and the procedure will take place after induction of anaesthesia.
Control group
Active

Outcomes
Primary outcome [1] 5245 0
Speed of intubation. This will be measured using a stop-watch (seconds) by one of the study investigators who is also an anaesthetist.
Timepoint [1] 5245 0
At time of intubation, immediately after induction of anaesthesia. Intubation is predicted to take 30-60 seconds.
Secondary outcome [1] 8843 0
Incidence of difficult tracheal intubation. This will be assessed by the anaesthetist performing the intubation. Difficulty of intubation will be assessed via the intubation difficulty score (IDS) which is a validated measure of the difficulty of intubation.
Timepoint [1] 8843 0
At time of intubation, immediately after induction of anaesthesia.
Secondary outcome [2] 8844 0
Laryngoscopic view will be assessed by the established Cormack/Lehane grading system. This grading system applies grades to the view depending on how much of the larynx is seen.
Timepoint [2] 8844 0
At time of intubation, immediately after induction of anaesthesia.
Secondary outcome [3] 8845 0
Incidence of complications will be assessed when one of the study investigators reviews the patient in recovery ie. after they have woken up from surgery.
Timepoint [3] 8845 0
At the end of the procedure
Secondary outcome [4] 8846 0
Success rate of intubation will be calculated by dividing attempts at intubation by successful intubation.
Timepoint [4] 8846 0
At time of intubation, immediately after induction of anaesthesia.

Eligibility
Key inclusion criteria
American Society Anesthesia physical status grading system (ASA) 1-3 patients requiring endotracheal intubation for surgery; English speaking; full frontal dentition
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient who requires an awake intubation; patient with known laryngeal pathology; patient at risk of pulmonary aspiration; body mass index (BMI)>40; patient refusal

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study subjects will be identified via the theatre list. Potential subjects will then be given information about the study and if they are keen to participate they will undergo full informed consent and sign a consent form. They will then be randomised to either the Macintosh or McGrath intubation group. Randomisation will occur with allocation concealment using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur via computer generated random number sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomisation will determine whether the McGrath or Macintosh laryngoscope is used for intubation. However, laryngoscopy will be performed with the alternative laryngoscope prior to intubation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4333 0
Hospital
Name [1] 4333 0
Alfred Hospital
Country [1] 4333 0
Australia
Funding source category [2] 4538 0
Other
Name [2] 4538 0
Whole time medical specialist fund, Alfred Hospital
Country [2] 4538 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Whole time medical specialist fund.
Address
Commercial Road, Prahran, 3181, Victoria.
Country
Australia
Secondary sponsor category [1] 4094 0
None
Name [1] 4094 0
Address [1] 4094 0
Country [1] 4094 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6587 0
Project has been submitted to Alfred Hospital Ethics Committee, approval pending because we don't have a ANZCTR trial number
Ethics committee address [1] 6587 0
Ethics committee country [1] 6587 0
Australia
Date submitted for ethics approval [1] 6587 0
20/01/2009
Approval date [1] 6587 0
Ethics approval number [1] 6587 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35064 0
Address 35064 0
Country 35064 0
Phone 35064 0
Fax 35064 0
Email 35064 0
Contact person for public queries
Name 12411 0
Dr. Maryanne Balkin
Address 12411 0
Alfred Hospital, Commercial Road, Prahran, 3181, VIC
Country 12411 0
Australia
Phone 12411 0
+61 3 90762000
Fax 12411 0
Email 12411 0
[email protected]
Contact person for scientific queries
Name 3339 0
Dr. Pierre Bradley
Address 3339 0
Alfred Hospital, Commercial Road, Prahran, 3181, VIC
Country 3339 0
Australia
Phone 3339 0
+61 3 90762000
Fax 3339 0
Email 3339 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.