Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000804886
Ethics application status
Approved
Date submitted
30/04/2021
Date registered
25/06/2021
Date last updated
25/11/2021
Date data sharing statement initially provided
25/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of patients in cardiac arrest due to ventricular arrhythmias to determine if manual pressure augmentation during defibrillation improves neurological outcome and survival
Scientific title
Investigating the effect of manual pressure augmentation in defibrillation of ventricular fibrillation and ventricular tachycardia on time to return of organised rhythm, neurological outcome and survival of cardiac arrest patients in a shockable rhythm
Secondary ID [1] 304101 0
None
Universal Trial Number (UTN)
Trial acronym
AUGMENT-VA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest 321774 0
Coronary Heart Disease 321775 0
Ventricular Arrhythmia 321776 0
Condition category
Condition code
Cardiovascular 319506 319506 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the treatment arm who have a shockable rhythm (VF or VT) will undergo defibrillation of 200J. During shock delivery, paramedics will apply manual maximum pressure to both defibrillation patches while the charge is delivered. If return of spontaneous circulation (ROSC) is not achieved, CPR is continued. Every 2 minutes, a rhythm check will be conducted and if the patient is still in a shockable rhythm, another shock will be given with manual pressure augmentation. This process will be repeated each time a shock is given as per the standard resuscitation protocol until ROSC is achieved or resuscitation is ceased. The treatment will be administered by Advanced Life Support and Mobile Intensive Care paramedics and training will be provided via a single 30 minute online learning module and face to face scenario training prior to the trial commencing. Paramedics will also have ongoing access to a trial intranet page with Q&A content and training videos. Trial participation will be voluntary for paramedics and a review of ambulance patient care records will be conducted for each arrest to determine if the intervention was utilised.
Intervention code [1] 320429 0
Treatment: Other
Comparator / control treatment
Patients in the control group will receive 200J defibrillation as per the standard resuscitation guidelines without any manual pressure augmentation applied.
Control group
Active

Outcomes
Primary outcome [1] 327374 0
Survival to hospital discharge - this data will be obtained from the Victorian Ambulance Cardiac Arrest Registry (VACAR) which routinely collects hospital outcome data
Timepoint [1] 327374 0
Hospital discharge
Primary outcome [2] 327375 0
Conversion of shockable rhythm - this data will be collected from Ambulance patient care records and Zoll data collected from the Zoll monitors utilised to monitor patients during cardiac arrest.
Timepoint [2] 327375 0
End of arrest (return of spontaneous circulation or death)
Secondary outcome [1] 394843 0
Neurological outcome at 12 months post cardiac arrest measured by Glasgow Outcome Scale-Extended (GOS-E). This will be obtained from VACAR data, as 12 month follow-up is routinely conducted by VACAR.
Timepoint [1] 394843 0
Hospital discharge and 12 months post arrest
Secondary outcome [2] 394844 0
Survival to hospital as determined by pulse present on arrival to hospital by manual assessment and Zoll monitor
Timepoint [2] 394844 0
Arrival to hospital
Secondary outcome [3] 394851 0
Paramedic compliance using manual pressure augmentation as determined by review of ambulance patient care records
Timepoint [3] 394851 0
At the conclusion of the study
Secondary outcome [4] 394852 0
Acceptability and ease of use of manual pressure augmentation by paramedics as assessed by a study-specific questionnaire administered to paramedics who have utilised MPA.
Timepoint [4] 394852 0
Within 2 weeks post arrest

Eligibility
Key inclusion criteria
Adults (18 years of age and over)
Confirmed out-of-hospital cardiac arrest
In a shockable rhythm (ventricular fibrillation or ventricular tachycardia) at the time of ambulance arrival
Suitable for resuscitation to commence/continue by paramedics
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dangers at scene preventing safe defibrillation
Trauma
Female who is known or suspected to be pregnant
Dependent on others for activities of daily living
"Not for Resuscitation" or Advanced Care Directive in place
Terminal illness

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation will be performed by ambulance branch
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This project plans to enrol 1498 patients. An interim analysis will be conducted after 750 patients have been enrolled and the DSMB will conduct a review of compliance rates, cluster sizes and intraclass correlation and determine if changes to the sample size are required.

Descriptive statistics will be presented as frequencies and proportions, with comparisons across groups using the chi square test. Normally distributed variables will be presented as means and standard deviations, and non-normally distributed variables will be presented as medians and interquartile range. Statistical significance will be defined as p<0.05, two tailed. Qualitative data from the survey tool will be analysed using thematic and content analysis and presented as a descriptive response.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
1498
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308485 0
Government body
Name [1] 308485 0
NHMRC
Country [1] 308485 0
Australia
Primary sponsor type
Government body
Name
Ambulance Victoria
Address
31 Joseph Street
Blackburn North VIC 3130
Country
Australia
Secondary sponsor category [1] 309329 0
None
Name [1] 309329 0
Address [1] 309329 0
Country [1] 309329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308437 0
Alfred HREC
Ethics committee address [1] 308437 0
Ethics committee country [1] 308437 0
Australia
Date submitted for ethics approval [1] 308437 0
13/04/2021
Approval date [1] 308437 0
04/06/2021
Ethics approval number [1] 308437 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110710 0
Prof Karen Smith
Address 110710 0
Ambulance Victoria
31 Joseph Street
Blackburn North 3031
Country 110710 0
Australia
Phone 110710 0
+61 3 9896 6083
Fax 110710 0
Email 110710 0
[email protected]
Contact person for public queries
Name 110711 0
Alex Voskoboinik
Address 110711 0
Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 110711 0
Australia
Phone 110711 0
+61 3 9509 5009
Fax 110711 0
Email 110711 0
[email protected]
Contact person for scientific queries
Name 110712 0
Karen Smith
Address 110712 0
Ambulance Victoria
31 Joseph Street
Blackburn North 3031
Country 110712 0
Australia
Phone 110712 0
+61 3 9896 6083
Fax 110712 0
Email 110712 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


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
SourceTitleYear of PublicationDOI
EmbaseFirst time use of manual pressure augmentation for ventricular fibrillation arrest in the community.2022https://dx.doi.org/10.1016/j.resuscitation.2022.03.018
N.B. These documents automatically identified may not have been verified by the study sponsor.