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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Direct View Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Intubation

Condition category

Condition code

Anaesthesiology

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]

Treatment: Devices

Comparator / control treatment

Laryngoscopy with a standard metal macintosh blade.

Control group

Active

Outcomes

Primary outcome [1]

Best laryngoscopic View

Timepoint [1]

At the time of laryngoscopy

Secondary outcome [1]

Best laryngoscopic view without backwards upwards rightwards pressure (BURP)

Timepoint [1]

At the time of laryngoscopy

Secondary outcome [2]

Requirement of intubation aid (bougie/stylet)

Timepoint [2]

At the time of intubation

Secondary outcome [3]

Best laryngoscopic view accounting for which blade was used first

Timepoint [3]

At the time of laryngoscopy

Secondary outcome [4]

Best laryngoscopic view without backwards upwards rightwards pressure (BURP) accounting for which blade was used first

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

https://www.austin.org.au/Office-for-Research/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/07/2023

Approval date [1]

19/09/2023

Ethics approval number [1]

HREC/98048/Austin-2023

Summary

Brief summary

The aim of this study is to compare the views of the larynx or voice box obtained by two different commonly used laryngoscopes. A laryngoscope is a device designed to visualize a voice box to place a breathing tube into the trachea for airway support and safety during surgery. The two laryngoscopes are a Macintosh laryngoscope and a GlideScope Spectrum DirectView MAC™ video laryngoscope which are both commonly used throughout Australia and internationally in current practice.
Video laryngoscopes, such as the GlideScope Spectrum DirectView MAC™, are commonly used for teaching medical professionals how to place breathing tubes. However, there is no evidence to confirm that the view of the voice box obtained with the GlideScope Spectrum DirectView MAC™ is the same as the standard Macintosh laryngoscope and this may have implications for quality of training.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Timothy Makar

Address

Austin Hospital, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94965704

Fax

[email protected]

Contact person for public queries

Name

Timothy Makar

Address

Austin Hospital, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94965704

Fax

[email protected]

Contact person for scientific queries

Name

Timothy Makar

Address

Austin Hospital, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94965704

Fax

[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.

Trial Review

Documents added manually

Documents added automatically