Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000018819
Ethics application status
Approved
Date submitted
30/10/2020
Date registered
13/01/2021
Date last updated
25/02/2022
Date data sharing statement initially provided
13/01/2021
Date results information initially provided
25/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of fibreoptic-guided intubation through an i-gel versus hyperangulated video laryngoscopy by emergency physicians: a prospective randomised study in cadavers.
Scientific title
Comparison of fibreoptic-guided intubation through an i-gel versus hyperangulated video laryngoscopy by emergency physicians: a prospective randomised study in cadavers.
Secondary ID [1] 302662 0
None
Universal Trial Number (UTN)
U1111-1260-5612
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult Airway 319573 0
Condition category
Condition code
Emergency medicine 317518 317518 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standardised flexible airway scope guided intubation technique via an i-gel supraglottic airway device (SGA), placed orally by an emergency physician (EP) with preliminary training consisting of a 60 minute training session on scope familiarisation, practice on an airway mannequin, and then on a cadaver.

It is anticipated that the intubation technique will be completed within 2 minutes.
During the procedure the process will be supervised by an experienced emergency physician, familiar with the technique, who is able to offer advice on the procedure.

Regarding the 'wash out' period:
The individual physician will undertake both the intervention and comparator techniques on the cadavers as part of a randomised sequence of experiments. As such there will be no 'wash out'; In theory the random sequence could mean, for example, 'physician 2' to perform FAS then HAVL one immediately after the other on the same cadaver.
Intervention code [1] 318948 0
Treatment: Devices
Comparator / control treatment
Standardised hyperangulated video laryngoscope (HAVL) guided intubation technique using a endotracheal tube (ETT) mounted on a stylet.

It is anticipated that the intubation technique will be completed within 2 minutes.
During the procedure the process will be supervised by an experienced emergency physician, familiar with the technique, who is able to offer advice on the procedure.
Control group
Active

Outcomes
Primary outcome [1] 325554 0
Time to successful placement of cuffed endotracheal tube, from start of procedure, using a digital stopwatch.
Timepoint [1] 325554 0
Successful endotracheal tube insertion into the trachea with balloon inflation.
Secondary outcome [1] 388372 0
Success or failure within two minutes of starting the procedure. A digital stopwatch will be used for this assessment.
Timepoint [1] 388372 0
Two minutes from disconnecting the bag-valve-mask.

Eligibility
Key inclusion criteria
Emergency Physician with preliminary training on use of the flexible airway scope.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2021
Actual
17/02/2021
Date of last participant enrolment
Anticipated
Actual
17/02/2021
Date of last data collection
Anticipated
Actual
17/02/2021
Sample size
Target
4
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17920 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 31783 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 307102 0
Hospital
Name [1] 307102 0
Emergency & Trauma Centre
Country [1] 307102 0
Australia
Primary sponsor type
Hospital
Name
Emergency & Trauma Centre
Address
The Alfred Hospital
55 Commercial Road
Melbourne
Victoria
3004
Country
Australia
Secondary sponsor category [1] 307671 0
None
Name [1] 307671 0
Address [1] 307671 0
Country [1] 307671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307216 0
The University of Melbourne Human Ethics Advisory Group
Ethics committee address [1] 307216 0
The University of Melbourne Human Ethics Advisory Group
Office of Research Ethics and Integrity (OREI)
The University of Melbourne
1/21 Bedford St
North Melbourne
Victoria
AUSTRALIA 3010
Ethics committee country [1] 307216 0
Australia
Date submitted for ethics approval [1] 307216 0
30/09/2020
Approval date [1] 307216 0
01/10/2020
Ethics approval number [1] 307216 0
2058001

Summary
Brief summary
In this study we have chosen to compare a standard approach to the intubation of a difficulty airway, using hyperangulated video laryngoscopy (HAVL), with a novel method where the endoscope is guided into the trachea through a supraglottic airway device (SGA). We feel this is a scenario likely to be encountered by emergency physicians as these devices are commonly used in this setting as a ‘rescue device’, which can temporarily allow ventilation when traditional laryngoscopy has failed to secure a definitive airway.

Our hypothesis is that intubation facilitated by a fiberoptic airway scope inserted via an SGA will allow an emergency physician to rapidly achieve a secure airway, when compared with HAVL, as these devices are designed to open directly at the laryngeal inlet and so may be an ideal conduit for endoscopic intubation of the trachea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106438 0
Dr Christopher Groombridge
Address 106438 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 106438 0
Australia
Phone 106438 0
+61 390763405
Fax 106438 0
Email 106438 0
[email protected]
Contact person for public queries
Name 106439 0
Dr Christopher Groombridge
Address 106439 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 106439 0
Australia
Phone 106439 0
+61 390763405
Fax 106439 0
Email 106439 0
[email protected]
Contact person for scientific queries
Name 106440 0
Dr Christopher Groombridge
Address 106440 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 106440 0
Australia
Phone 106440 0
+61 390763405
Fax 106440 0
Email 106440 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
Analysed data will be submitted for publication.
Individual participant data will not be made available in order to maintain the privacy of the small sample of physicians from this single centre emergency department.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Groombridge CJ, Maini A, Mathew J, Fritz P, Kim Y,... [More Details]
Plain language summaryNo Successful intubation of the trachea without airwa... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIGlobal Research Highlights2023https://doi.org/10.1007/s43678-023-00532-z
N.B. These documents automatically identified may not have been verified by the study sponsor.