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Trial registered on ANZCTR


Registration number
ACTRN12619001034123
Ethics application status
Approved
Date submitted
19/06/2019
Date registered
19/07/2019
Date last updated
10/12/2019
Date data sharing statement initially provided
19/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two intubation aids in the management of anticipated difficult tracheal intubation
Scientific title
Flexible Tip Bougie versus C-MAC Stylet in the management of anticipated difficult intubation in patients undergoing elective surgery. A pilot study
Secondary ID [1] 298460 0
None
Universal Trial Number (UTN)
U1111-1235-0991
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult Intubation 313218 0
Condition category
Condition code
Anaesthesiology 311667 311667 0 0
Other anaesthesiology
Respiratory 311927 311927 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Construct Medical Flexible Tip Bougie (the intervention) will be used to assist with intubation in patients requiring videolaryngoscopy with a CMAC D-Blade.

The Construct Medical Flexible Tip Bougie is an alternative tool, also designed to overcome the "can see, can’t intubate" scenario. This device incorporates a slider, controlled with the thumb and the forefinger, to guide the tip anteriorly, guiding it through the glottis. Furthermore, the ability to also flex the tip posteriorly once past the vocal cords, may avoid the problem of the ETT hitting the anterior tracheal wall and impeding passage of the tube. , Once manipulated into position, the ETT is passed over the bougie, into the trachea.

The intubation will be performed by an anaesthetist with at least 3 years anaesthesia experience. A single intubation will be performed for each recruited patient, following the induction anaesthesia.

Details of whether or not the patient was successfully intubated with the allocated device will be collected on the case report form, including which, if any, additional airway devices were required.
Intervention code [1] 314703 0
Treatment: Devices
Comparator / control treatment
The GlideRite Rigid Stylet (the comparator) will be used to assist with intubation in patients requiring videolaryngoscopy with a CMAC D-Blade

The GlideRite® Rigid Stylet has been shown to reduce time to successful intubation with a D-blade videolaryngoscope and is currently the standard intubation introducer used with the D-Blade at Sir Charles Gairdner Hospital. The curve of the stylet matches the curvature of the D-blade, and the ETT is pre-loaded over the stylet. Unlike the flexible-top bougie there is no ability to manipulate the direction or curvature of the device mid-intubation.

As with the flexible tip bougie, the intubation will be performed by an anaesthetist with at least 3 years anaesthesia experience. A single intubation will be performed for each recruited patient, following the induction anaesthesia.

Details of whether or not the patient was successfully intubated with the allocated device will be collected on the case report form, including which, if any, additional airway devices were required.
Control group
Active

Outcomes
Primary outcome [1] 320375 0
Time taken to successful intubation.
Timepoint [1] 320375 0
Single time point for each patient. Successful intubation defined as the time from anaesthetist first taking hold of the introducer, to confirmation of successful intubation by visualisation of a capnography trace on the monitor
Secondary outcome [1] 371704 0
Number of intubation attempts required, recorded on case report form by the intubating anaesthetist
Timepoint [1] 371704 0
At time of intubation
Secondary outcome [2] 371705 0
Additional adjuncts required to achieve successful intubation (Y/N). This will be reported by the intubating anaesthetist on the case report form following successful intubation
Timepoint [2] 371705 0
At time of intubation
Secondary outcome [3] 371706 0
Anaesthetist rated ease of use of device: recorded on a Likert scale (1-5) by intubating anaesthetist
Timepoint [3] 371706 0
Following successful intubation

Eligibility
Key inclusion criteria
• Adults (>18years) able to provide informed consent
• Booked for elective, non-cardiac surgery
• Presence of at least one predictor of increased difficulty of intubation
(Any of: prior history of difficult intubation, thyromental distance (<6cm), mouth opening (<2cm), decreased neck extension, Mallampati grade 3+, decreased jaw protrusion)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age under 18 years
• Unable to give informed consent to participate
• Would not routinely require routine endotracheal intubation for the surgical procedure
• Known disease of airway (tumour, infection, tracheal stenosis, tracheomalacia)
• Recent airway surgery (within 6 weeks)
• Difficult airway necessitating awake intubation
• Allergy to fentanyl, propofol or rocuronium

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online computerised sequence generation (sealedenvelope.com),
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Standard biographical data and surgical information for each group will be compared with descriptive statistics. Comparison of means and standard deviations of groups. Given the nature of this pilot study no inferential statistical analysis will be performed. No interim analysis is planned

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2019
Actual
29/07/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
2/09/2019
Date of last data collection
Anticipated
30/09/2019
Actual
2/09/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14015 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 26800 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303003 0
Hospital
Name [1] 303003 0
Sir Charles Gairdner Hospital
Country [1] 303003 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue, NEDLANDS, WA, 6009
Country
Australia
Secondary sponsor category [1] 302971 0
None
Name [1] 302971 0
N/A
Address [1] 302971 0
N/A
Country [1] 302971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303553 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 303553 0
Ethics committee country [1] 303553 0
Australia
Date submitted for ethics approval [1] 303553 0
Approval date [1] 303553 0
12/09/2018
Ethics approval number [1] 303553 0

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

Contacts
Principal investigator
Name 94062 0
Dr Dale Currigan
Address 94062 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands, WA, 6009
Country 94062 0
Australia
Phone 94062 0
+61864573333
Fax 94062 0
Email 94062 0
dcurrigan@gmail.com
Contact person for public queries
Name 94063 0
Dale Currigan
Address 94063 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands, WA, 6009
Country 94063 0
Australia
Phone 94063 0
+61864573333
Fax 94063 0
Email 94063 0
dcurrigan@gmail.com
Contact person for scientific queries
Name 94064 0
Dale Currigan
Address 94064 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands, WA, 6009
Country 94064 0
Australia
Phone 94064 0
+61864573333
Fax 94064 0
Email 94064 0
dcurrigan@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.