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Trial registered on ANZCTR


Registration number
ACTRN12618000271202
Ethics application status
Approved
Date submitted
23/01/2018
Date registered
22/02/2018
Date last updated
20/01/2020
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing a novel videolaryngoscope with conventional Glidescope® videolaryngoscope in simulated difficult airway: a manikin study
Scientific title
Comparing intubation by anaesthesiology staff of a simulated difficult airway using a novel video laryngoscope and conventional Glidescope® videolaryngoscope: a manikin study
Secondary ID [1] 293859 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult airway 306322 0
Condition category
Condition code
Anaesthesiology 305406 305406 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will 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 Glidescope® videolaryngoscope, or Group 2: Glidescope® videolaryngoscope followed by novel videolaryngoscope. The novel videolaryngoscope is similar to the glidescope in terms of blade design. However, the screen and the technology connecting between the videocamera and the screen are different. The novel videolaryngoscope has not been tested before in mannikin or human.

Each participant will receive standardized instruction for the use of each device as per the manufacturer’s guidelines before the commencement of the study. The difficult airway will be simulated using tongue swelling in the SimMan patient simulator (Laerdal Medical).

The duration of the intervention will be about 5 minutes (time required to intubate the manikin). It will be a one-on-one face-to-face assessment between the observer and the participant. The participants will be using both the control device and the intervention 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] 300120 0
Treatment: Devices
Comparator / control treatment
The control group involves the use of the Glidescope® video laryngoscope. The new video laryngoscope has not been tested before. We choose to compare this new videolaryngsocope with the Glidescope video laryngoscope because the blade design of both devices is similar. Both videolaryngoscopes have a high-resolution camera and light source embedded at the distal end of the blade. It allows the view of anterior glottis without the need for direct line of sight. The image is displayed on a coloured monitor.
Control group
Active

Outcomes
Primary outcome [1] 304540 0
The time taken for successful tracheal intubation
Timepoint [1] 304540 0
It is measured from the time the videolaryngoscope is handed to the participant to when the participant declare successful intubation, with censoring of failed intubation. It is recorded by an independent observer.
Secondary outcome [1] 342323 0
Number of failed intubation
Timepoint [1] 342323 0
Failure is defined as unrecognized oesophageal intubation, abandoned procedure, intubation taking >120 seconds or > 3 attempts of intubation. It is recorded by an independent observer.
Secondary outcome [2] 342324 0
Number of intubation attempts
Timepoint [2] 342324 0
An attempt is defined as removal of videolaryngoscope or endotracheal tube from the mouth without declaration of successful intubation. It is recorded by an independent observer.
Secondary outcome [3] 342325 0
Number of intubating adjuncts used.
Timepoint [3] 342325 0
It is recorded by an independent observer at the time of intubation.
Secondary outcome [4] 342326 0
The best laryngoscopy view achieved using the Cormack and Lehane grading system (Grade I to IV).
Timepoint [4] 342326 0
It is recorded by an independent observer at the time of intubation.
Secondary outcome [5] 342327 0
The ease of intubation, which will be surveyed using a visual analogue scale from 0-100mm.
Timepoint [5] 342327 0
It is recorded by an independent observer at the time of intubation.
Secondary outcome [6] 342543 0
Type of intubating adjuncts used.
Timepoint [6] 342543 0
It is recorded by an independent observer at the time 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
Gender
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 Glidescope® videolaryngoscope, or Group 2: Glidescope® videolaryngoscope 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 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9853 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 18637 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 298480 0
Hospital
Name [1] 298480 0
Royal Melbourne Hospital
Address [1] 298480 0
Grattan Street, Parkville, Vic 3050
Country [1] 298480 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan Street, Parkville, Vic 3050
Country
Australia
Secondary sponsor category [1] 297620 0
None
Name [1] 297620 0
Address [1] 297620 0
Country [1] 297620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299467 0
Melbourne Health Research and Ethics Committee
Ethics committee address [1] 299467 0
Royal Melbourne Hospital, Grattan Street, Parkville, Vic 3050
Ethics committee country [1] 299467 0
Australia
Date submitted for ethics approval [1] 299467 0
22/09/2017
Approval date [1] 299467 0
18/12/2017
Ethics approval number [1] 299467 0
QA2017072

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 withdifficult 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. We are comparing it with the widely used Glidescope® video laryngoscope. The reason for comparing these two devices is because the blade design of both devices is similar. We hypothesise that In simulated difficult airways, the novel
videolaryngoscope allows a faster tracheal intubation time as compared to the Glidescope® video laryngoscope.

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 Glidescope® videolaryngoscope, or Group 2: Glidescope® videolaryngoscope followed by novel videolaryngoscope.

The primary outcome is the time taken for successful tracheal intubation. Secondary outcomes include: the number of failed intubation, the number of intubation attempts, the number and type of intubating adjuncts used, the best laryngoscopy view achieved and the ease of intubation.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2395 2395 0 0
Attachments [2] 2396 2396 0 0
Attachments [3] 2397 2397 0 0
/AnzctrAttachments/374361-QA2017072_consent V2_clean.doc (Participant information/consent)
Attachments [4] 2398 2398 0 0
/AnzctrAttachments/374361-QA2017072 approval.docx (Ethics approval)

Contacts
Principal investigator
Name 80502 0
Dr Irene Ng
Address 80502 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050.
Country 80502 0
Australia
Phone 80502 0
+61 3 93427540
Fax 80502 0
+61 3 93428623
Email 80502 0
Irene.Ng@mh.org.au
Contact person for public queries
Name 80503 0
Dr Irene Ng
Address 80503 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050.
Country 80503 0
Australia
Phone 80503 0
+61 3 93427540
Fax 80503 0
+61 3 93428623
Email 80503 0
Irene.Ng@mh.org.au
Contact person for scientific queries
Name 80504 0
Dr Irene Ng
Address 80504 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050.
Country 80504 0
Australia
Phone 80504 0
+61 3 93427540
Fax 80504 0
+61 3 93428623
Email 80504 0
Irene.Ng@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No data will be shared.
What supporting documents are/will be available?
No other documents available
Summary results
No Results