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Trial registered on ANZCTR


Registration number
ACTRN12618000158268
Ethics application status
Approved
Date submitted
16/01/2018
Date registered
1/02/2018
Date last updated
29/06/2021
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing a novel videolaryngoscope with the Macintosh in simulated difficult airway: a manikin study
Scientific title
Comparing a novel videolaryngoscope with the Macintosh in simulated difficult airway: a manikin study
Secondary ID [1] 293791 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult airway 306194 0
Condition category
Condition code
Anaesthesiology 305307 305307 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are comparing the effectiveness of a newly available video laryngoscope with the standard direct laryngoscopy by using the Macintosh blade in performing endotracheal intubation in a manikin with simulated difficult airway.

Each participant will receive standardized instruction for the use of each device as per the manufacturer’s guidelines before the commencement of the study. All participants will be tested on using each of the two intubation devices on a manikin with a simulated difficult airway. Participants will be assigned to one of the two groups – Group 1: novel videolaryngoscope followed by Macintosh laryngoscope, or Group 2: Macintosh laryngoscope followed by novel videolaryngoscope.

The intervention will be delivered once only in both groups. Intervention fidelity will not be assessed but participants will be observed directly while using the new device. There will not be any wash-out period between the time when the control device is used and the time when the intervention device is used.

Intervention code [1] 300119 0
Treatment: Devices
Comparator / control treatment
The control group involves the use of a standard direct laryngoscopy with a Macintosh blade, This is different from the new video laryngoscope which requires indirect laryngoscopy technique.
Control group
Active

Outcomes
Primary outcome [1] 304467 0
The best laryngoscopy view achieved with the videolaryngoscope using the Cormack and Lehane grading system (Grade I to IV)
Timepoint [1] 304467 0
At time of intubation
Secondary outcome [1] 342048 0
The time taken for successful tracheal intubation.
Timepoint [1] 342048 0
It is measured from the time the videolaryngoscope or Macintosh blade is handed to the participant to when the participant declare successful intubation, with censoring of failed intubation.
Secondary outcome [2] 342049 0
Number of failed intubation
Timepoint [2] 342049 0
Failure is defined as unrecognized oesophageal intubation, abandoned procedure, intubation taking >120 seconds or > 3 attempts of intubation.
Secondary outcome [3] 342050 0
Number of intubation attempts.
Timepoint [3] 342050 0
An attempt is defined as removal of videolaryngoscope/Macintosh blade or endotracheal tube from the mouth without declaration of successful intubation.
Secondary outcome [4] 342051 0
Number and type of intubating adjuncts used. It will be recorded by an independent observer.
Timepoint [4] 342051 0
At the time of intubation
Secondary outcome [5] 342052 0
The ease of intubation, which will be surveyed using a visual analogue scale from 0-100mm.
Timepoint [5] 342052 0
At the end of intubation

Eligibility
Key inclusion criteria
Anaesthetic residents, registrars or consultants who work at the Royal Melbourne Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
The allocation will be put in individually numbered and sealed envelopes before recruitment. The person responsible for recruitment will be unaware of the allocation result. The allocation is revealed only after participant consent is obtained for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned, according to the computer-generated randomisation result, to one of the two groups – Group 1: novel videolaryngoscope followed by Macintosh laryngoscope, or Group 2: Macintosh laryngoscope followed by novel videolaryngoscope.
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
Values will be expressed as mean and standard deviation. Median and interquartile ranges will be used for data, which are not normally distributed. Comparisons between the groups will be performed by paired t-test for parametric continuous data and Wilcoxon’s signed rank test for non-parametric or not normally distributed continuous data. Chi-square or Fisher exact test will be used for categorical data. A P value < 0.05 is considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
Date of last participant enrolment
Anticipated
21/10/2022
Actual
Date of last data collection
Anticipated
21/11/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9787 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 18564 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 298408 0
Hospital
Name [1] 298408 0
Royal Melbourne Hospital
Country [1] 298408 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan Street, Parkville, Vic 3050
Country
Australia
Secondary sponsor category [1] 297544 0
None
Name [1] 297544 0
Address [1] 297544 0
Country [1] 297544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299406 0
Melbourne Health Research and Ethics Committee
Ethics committee address [1] 299406 0
Royal Melbourne Hospital, Grattan Street, Parkville, Vic 3050
Ethics committee country [1] 299406 0
Australia
Date submitted for ethics approval [1] 299406 0
22/09/2017
Approval date [1] 299406 0
18/12/2017
Ethics approval number [1] 299406 0
QA2017073

Summary
Brief summary
Airway or respiratory complication is one of leading causes of morbidity and mortality in anaesthesia. There are different techniques and intubating equipment (laryngoscope) available for anaesthetists to deal with difficult airways. Anaesthetists use their knowledge and previous experience to decide which type of laryngoscope to use in these cases.

In this study, we are evaluating, for the first time, this newly available videolaryngoscope. It requires a technique called "indirect laryngoscopy". We are comparing it with the standard direct laryngoscopy by using the Macintosh blade. We hypothesise that In simulated difficult airways, the novel videolaryngoscope achieve a better laryngoscopy view as compared to the Macintosh blade.

We will prospectively recruit 30 voluntary anaesthetic residents, registrars or consultants for this study. All participants will be tested on using each of the two intubation devices on a manikin with a simulated difficult airway. Participants will be assigned to one of the two groups – Group 1: novel videolaryngoscope followed by Macintosh laryngoscope, or Group 2: Macintosh laryngoscope followed by novel videolaryngoscope.

The primary outcome is the best laryngoscopy view achieved.
Secondary outcomes include:
• The time taken for successful tracheal intubation.
• Number of failed intubation.
• Number of intubation attempts.
• Number and type of intubating adjuncts used.
• The ease of intubation, which will be surveyed using a visual analogue scale from 0-100mm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80290 0
Dr Irene Ng
Address 80290 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050.
Country 80290 0
Australia
Phone 80290 0
+61 3 93427540
Fax 80290 0
+61 3 93428623
Email 80290 0
[email protected]
Contact person for public queries
Name 80291 0
Dr Irene Ng
Address 80291 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050.
Country 80291 0
Australia
Phone 80291 0
+61 3 93427540
Fax 80291 0
+61 3 93428623
Email 80291 0
[email protected]
Contact person for scientific queries
Name 80292 0
Dr Irene Ng
Address 80292 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050.
Country 80292 0
Australia
Phone 80292 0
+61 3 93427540
Fax 80292 0
+61 3 93428623
Email 80292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data are to be remained anonymous.


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.