Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000995875
Ethics application status
Approved
Date submitted
13/07/2021
Date registered
28/07/2021
Date last updated
30/06/2022
Date data sharing statement initially provided
28/07/2021
Date results information initially provided
30/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial in cadavers investigating methods for intubation via a supraglottic airway device: comparison of fibre-optic-guided versus a modified retrograde technique performed by emergency physicians
Scientific title
A randomised controlled trial in cadavers investigating methods for intubation via a supraglottic airway device: comparison of fibre-optic-guided versus a modified retrograde technique performed by emergency physicians
Secondary ID [1] 304769 0
Nil known
Universal Trial Number (UTN)
U1111-1267-9772
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult Airway 322824 0
Condition category
Condition code
Emergency medicine 320414 320414 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Retrograde wire 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 kit familiarisation, practice on an airway mannequin, and then on a cadaver.

It is anticipated that the intubation technique will be completed within 3 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 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'.
Intervention code [1] 321151 0
Treatment: Devices
Comparator / control treatment
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 3 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 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'.
Control group
Active

Outcomes
Primary outcome [1] 328245 0
Time to successful placement of cuffed endotracheal tube, from start of procedure, using a digital stopwatch.
Timepoint [1] 328245 0
Successful endotracheal tube insertion into the trachea with balloon inflation.
Secondary outcome [1] 398246 0
Success or failure within three minutes of starting the procedure. A digital stopwatch will be used for this assessment.
Timepoint [1] 398246 0
Three minutes from disconnecting the bag-valve-mask.

Eligibility
Key inclusion criteria
Emergency Physician with preliminary training on use of the retrograde intubation kits.
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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central 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
22/09/2021
Actual
22/09/2021
Date of last participant enrolment
Anticipated
Actual
22/09/2021
Date of last data collection
Anticipated
Actual
22/09/2021
Sample size
Target
4
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309139 0
Hospital
Name [1] 309139 0
Emergency & Trauma Centre, The Alfred Hospital
Country [1] 309139 0
Australia
Primary sponsor type
Hospital
Name
Emergency & Trauma Centre, The Alfred Hospital
Address
Emergency & Trauma Centre
The Alfred Hospital
55 Commercial Road
Melbourne
Victoria
3004
Country
Australia
Secondary sponsor category [1] 310093 0
None
Name [1] 310093 0
Address [1] 310093 0
Country [1] 310093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309006 0
The University of Melbourne Human Ethics Advisory Group
Ethics committee address [1] 309006 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] 309006 0
Australia
Date submitted for ethics approval [1] 309006 0
30/09/2020
Approval date [1] 309006 0
01/10/2020
Ethics approval number [1] 309006 0
1648354

Summary
Brief summary
In this study we have chosen to compare two options for intubation via 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.
The first method is a novel retrograde technique where the guidewire is passed via the SGA; this second method is a fibre-optic guided approach, also via the SGA.

Our theory is that intubation via an SGA will allow an emergency physician to reliably achieve a secure airway as these devices are designed to open directly at the laryngeal inlet and so may be an ideal conduit for either retrograde or fibre-optic intubation of the trachea. The null hypothesis is that there is no difference in the time taken to secure an endotracheal tube by these two methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112630 0
Dr Christopher Groombridge
Address 112630 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 112630 0
Australia
Phone 112630 0
+61 3 90763405
Fax 112630 0
Email 112630 0
[email protected]
Contact person for public queries
Name 112631 0
Dr Christopher Groombridge
Address 112631 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 112631 0
Australia
Phone 112631 0
+61 3 90763405
Fax 112631 0
Email 112631 0
[email protected]
Contact person for scientific queries
Name 112632 0
Dr Christopher Groombridge
Address 112632 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 112632 0
Australia
Phone 112632 0
+61 3 90763405
Fax 112632 0
Email 112632 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 cadaveric airway course.


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, Johnny C, McCreary D, Kim... [More Details]
Plain language summaryNo Successful tracheal intubation of cadavers by emer... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial in cadavers investigating methods for intubation via a supraglottic airway device: Comparison of flexible airway scope guided versus a retrograde technique.2022https://dx.doi.org/10.1111/1742-6723.13908
N.B. These documents automatically identified may not have been verified by the study sponsor.