Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000538448
Ethics application status
Approved
Date submitted
7/05/2025
Date registered
27/05/2025
Date last updated
27/05/2025
Date data sharing statement initially provided
27/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of views of the larynx obtained by direct laryngoscopy using a traditional Macintosh laryngoscope vs direct laryngoscopy using a GlideScope Spectrum DirectView MAC™ video laryngoscope
Scientific title
Comparison of views of the larynx obtained on simultaneous assessment by direct laryngoscopy using a traditional Macintosh laryngoscope vs direct laryngoscopy using a GlideScope Spectrum DirectView MAC™ video laryngoscope. Is the direct view comparable? Implications for the use of the GlideScope as a training tool.
Secondary ID [1] 314400 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Direct View Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation 337409 0
Condition category
Condition code
Anaesthesiology 333786 333786 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients scheduled for anaesthesia requiring endotracheal intubation will be randomised to direct laryngoscopy with either a Glidescope MAC blade or a standard MAC blade. Laryngoscopy will then be performed with this blade and the best airway grade will be recorded. Laryngoscopy will then be performed with the alternative blade and the best airway grade recorded followed by endotracheal intubation. Laryngoscopy will be performed by a consultant anaesthetist or provisional anaesthesia fellow. The trial will then be concluded.

The Glidescope MAC blade has the same shape as the standard MAC blade however it is made from plastic instead of metal and has a camera on the end to facilitate videolaryngoscopy. Videolaryngoscopy will not be utilised in this trial and only direct laryngoscopy (looking directly into the mouth) will be done.

Each laryngoscopy will take ~15-20 seconds. There will be no specific extra training as the Glidescope MAC blade is used in an identical manner to the standard MAC blade. There is no mandated rest period between blade use and they may be used immediately after each other.
Intervention code [1] 331008 0
Treatment: Devices
Comparator / control treatment
Laryngoscopy with a standard metal macintosh blade.
Control group
Active

Outcomes
Primary outcome [1] 341367 0
Best laryngoscopic View
Timepoint [1] 341367 0
At the time of laryngoscopy
Secondary outcome [1] 447333 0
Best laryngoscopic view without backwards upwards rightwards pressure (BURP)
Timepoint [1] 447333 0
At the time of laryngoscopy
Secondary outcome [2] 447334 0
Requirement of intubation aid (bougie/stylet)
Timepoint [2] 447334 0
At the time of intubation
Secondary outcome [3] 447335 0
Best laryngoscopic view accounting for which blade was used first
Timepoint [3] 447335 0
At the time of laryngoscopy
Secondary outcome [4] 447336 0
Best laryngoscopic view without backwards upwards rightwards pressure (BURP) accounting for which blade was used first
Timepoint [4] 447336 0
At the time of laryngoscopy

Eligibility
Key inclusion criteria
Adult participants requiring endotracheal intubation as part of their anaesthesia management
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy
- Body Mass Index greater than 40kg/m2
- ASA score of > 3
- Patients requiring rapid sequence induction
- Patients who require non-routine airway management.
- Patients who in the opinion of the treating anaesthetist are too unwell or unstable to participate safely.

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 numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using the blockrand package with R.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using a historical direct laryngoscopy data set with 663 participants by Yentis and Lee (Anaesthesia 1998) the mean and standard deviation of Cormack and Lehane view with direct laryngoscopy was calculated (1.4, 0.67). This was used to calculate sample size using a correction for non parametric data of 15%. Given an alpha of 0.05 and a beta of 0.9; 34 participants will need to be recruited to show that the median Cormack and Lehane Grade with a GlideScope Spectrum DirectView MAC™ is 2a and therefore significantly different than direct laryngoscopy with a standard MAC blade.
50 participants will be recruited to account for withdrawal.

Given paired ordinal data; comparison of C & L grades between standard MAC and GlideScope Spectrum DirectView MAC™ will be done using the Wilcoxon Signed-Rank Test. Quantitative differences will be presented as a Hodges Lehmann estimator with 95% CI. A generalised odds ratio with 95% CI will also be calculated. This will be repeated for secondary outcomes that look at grade.

Logistic regression will be used for the secondary outcome looking at intubation aid (bougie/stylet) use.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/09/2023
Date of last participant enrolment
Anticipated
30/05/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
50
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27914 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 44108 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 318918 0
Hospital
Name [1] 318918 0
Austin Hospital
Country [1] 318918 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 321390 0
None
Name [1] 321390 0
Address [1] 321390 0
Country [1] 321390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317535 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 317535 0
Ethics committee country [1] 317535 0
Australia
Date submitted for ethics approval [1] 317535 0
27/07/2023
Approval date [1] 317535 0
19/09/2023
Ethics approval number [1] 317535 0
HREC/98048/Austin-2023

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

Contacts
Principal investigator
Name 141354 0
Dr Timothy Makar
Address 141354 0
Austin Hospital, 145 Studley Road, Heidelberg, VIC, 3084
Country 141354 0
Australia
Phone 141354 0
+61 3 94965704
Fax 141354 0
Email 141354 0
[email protected]
Contact person for public queries
Name 141355 0
Timothy Makar
Address 141355 0
Austin Hospital, 145 Studley Road, Heidelberg, VIC, 3084
Country 141355 0
Australia
Phone 141355 0
+61 3 94965704
Fax 141355 0
Email 141355 0
[email protected]
Contact person for scientific queries
Name 141356 0
Timothy Makar
Address 141356 0
Austin Hospital, 145 Studley Road, Heidelberg, VIC, 3084
Country 141356 0
Australia
Phone 141356 0
+61 3 94965704
Fax 141356 0
Email 141356 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Insitutional policies



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.