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Trial registered on ANZCTR


Registration number
ACTRN12624000001594
Ethics application status
Approved
Date submitted
22/11/2023
Date registered
8/01/2024
Date last updated
21/01/2024
Date data sharing statement initially provided
8/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of posture change and/or hand gripping on venous cannulation induced vasovagal response
Scientific title
Effect of physical counter pressure maneuvers on the incidence of Vasovagal Response to Venous Cannulation in patients requiring Cardiac CT with contrast
Secondary ID [1] 310976 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasovagal reaction induced by venous cannulation 332061 0
Condition category
Condition code
Cardiovascular 328788 328788 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions will include posture change (supine position) and hand gripping (squeezing stress ball in the opposing arm to the venous cannulation). There will be three interventional groups:
1, Patient will assume supine position during PIVC (peripheral intravenous cannulation), patient will remain flat until either the patient requests to sit upright or is transferred to the CT scanner.
2, Patient will be in sitting position and squeeze a stress ball in opposing arm to the insertion of PIVC until the PIVC is secured.
3. Patient will assume supine position during the PIVC insertion, the patient will remain flat until either the patient requests to sit upright or is transferred to the CT scanner. Meanwhile Patient will be instructed to squeeze a stress ball in opposing arm to the insertion of PIVC until the PIVC is secured.
The interventions will continue until successful insertion of the PIVC. The primary nurse will be administering the relevant intervention under direct supervision of the research staff. Training will be provided to ensure all nursing staff in the Imaging department perform their tasks uniformly. Research staff will be always available onsite to provide supervision and monitor adherence to the interventions.
Intervention code [1] 327412 0
Prevention
Intervention code [2] 327413 0
Treatment: Other
Comparator / control treatment
Control group: patients will be treated with usual standard care following standard PIVC insertion guidelines, sitting upright in a chair during the procedure.
Control group
Active

Outcomes
Primary outcome [1] 336600 0
A difference in the incidence of vasovagal syncope between the four arms is the primary outcome measure of the study.
Timepoint [1] 336600 0
4 sets of clinical assessment will be carried out and recorded : baseline observation ( before starting of PIVC insertion), immediately after PIVC insertion, 10 minutes after and 30 minutes after.
Secondary outcome [1] 429009 0
Time to vagal response among patients who experience a vasovagal response.
Timepoint [1] 429009 0
5 sets of clinical assessment will be carried out and recorded: baseline observation (before starting of PIVC insertion), immediately after PIVC insertion, onset of vasovagal, 10 minutes after and 30 minutes after PIVC insertion.
Secondary outcome [2] 429641 0
Percentage of participants who experience vasovagal-like symptoms (as defined above) without a drop in HR and/or MAP.
Timepoint [2] 429641 0
5 sets of clinical assessment will be carried out and recorded: baseline observation ( before starting of PIVC insertion), immediately after PIVC insertion, onset of vasovagal,10 minutes after and 30 minutes after PIVC insertion.

Eligibility
Key inclusion criteria
Inclusion Criteria:
• Patients requiring Cardiac CT with contrast;
• Patients 18 years old and over.
• Patients able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
• Patients with contrast allergy.
• Patients not able to give informed consent.
• Patients with reduced upper extremity function and grip strength.
• Patients not tolerant of supine position.
• Peripheral neuropathy / neurological deficit.
• Hemodynamically unstable patients (Systolic BP [SBP]<100mmHg, HR<45BPM).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block and stratified randomization will be performed by a person who is not associated with the study using computer generated sets of random allocations. Assignments will be concealed in a consecutively numbered opaque envelope and kept in a locked cabinet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block and stratified randomization: using online software for random sequence generation, block size of 4 and 8, and age ( under 50 or 50 or over) as stratification factor.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/01/2024
Actual
Date of last participant enrolment
Anticipated
17/01/2025
Actual
Date of last data collection
Anticipated
17/01/2025
Actual
Sample size
Target
1228
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25867 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 41700 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 315235 0
Hospital
Name [1] 315235 0
Victoria Heart Hospital
Country [1] 315235 0
Australia
Primary sponsor type
Individual
Name
Rebecca Woodley
Address
Victorian Heart Hospital, 631 Blackburn road, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 317284 0
None
Name [1] 317284 0
Address [1] 317284 0
Country [1] 317284 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314159 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 314159 0
Ethics committee country [1] 314159 0
Australia
Date submitted for ethics approval [1] 314159 0
16/10/2023
Approval date [1] 314159 0
18/12/2023
Ethics approval number [1] 314159 0
RES-0000-705B

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

Contacts
Principal investigator
Name 130626 0
Mrs Rebecca Woodley
Address 130626 0
Victorian Heart Hospital, 631 Blackburn road, Clayton, VIC 3168
Country 130626 0
Australia
Phone 130626 0
+61 3 75112230
Fax 130626 0
Email 130626 0
rebecca.woodley@monashhealth.org
Contact person for public queries
Name 130627 0
Rebecca Woodley
Address 130627 0
Victorian Heart Hospital, 631 Blackburn road, Clayton, VIC 3168
Country 130627 0
Australia
Phone 130627 0
+61 3 75112230
Fax 130627 0
Email 130627 0
rebecca.woodley@monashhealth.org
Contact person for scientific queries
Name 130628 0
Sujie Martin
Address 130628 0
Victorian Heart Hospital, 631 Blackburn road, Clayton, VIC 3168
Country 130628 0
Australia
Phone 130628 0
+61 3 75112231
Fax 130628 0
Email 130628 0
sujie.martin@monashhealth.org

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20963Study protocol    386892-(Uploaded-05-12-2023-13-51-25)-Study-related document.docx
21002Informed consent form    386892-(Uploaded-05-12-2023-13-46-52)-Study-related document.docx



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.