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Trial registered on ANZCTR


Registration number
ACTRN12623000916640
Ethics application status
Approved
Date submitted
1/08/2023
Date registered
28/08/2023
Date last updated
28/08/2023
Date data sharing statement initially provided
28/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Right Brachiocephalic Vein Origin (RBCVO) Access for Trauma
Scientific title
Investigating the Feasibility of Right Brachiocephalic Vein Origin Intravenous Access for Resuscitation of Adult Trauma Patients
Secondary ID [1] 307198 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Injury 326425 0
Haemorrhagic Shock 326426 0
Trauma Resuscitation 326427 0
Condition category
Condition code
Emergency medicine 323706 323706 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective randomised control trial, which is aimed at assessing the efficacy and safety of the use of the Right Brachiocephalic Vein Origin (RBCVO) for vascular access for the resuscitation of shocked adult trauma patients by comparing the use of the RBCVO to the subclavian vein (SCV) for central venous access in shocked trauma resuscitation. Participants in this study will require central venous access as part of their resuscitation due to shock, lack of peripheral venous access, or need for central access for ongoing care.

Participants will be recruited as a convenience sample of subjects who have sustained major trauma at the Alfred Emergency and Trauma Centre. Participant selection and recruitment will be completed by Trauma Consultants, who have been trained in the proposed RBCVO access technique and have experience in inserting central venous catheters using landmark based techniques and ultrasound guidance.

Shocked adult trauma patients who require central venous access as part of their initial trauma reception and resuscitation will be randomised to SCV or RBCVO access. Central venous access will be gained to facilitate delivery of blood products and medication, for pressure injection of CT contrast for imaging studies or for central venous pressure monitoring.

Participants allocated to the study group (RBCVO Access) will have central venous access gained using an ultrasound guided supraclavicular access technique, targeting the RBCVO. The supraclavicular access technique involves visualising the RBCVO with ultrasound, gaining initial venous access with ultrasound guidance and inserting a central venous catheter.

The success rates, complication rates, and procedural difficulty of the access technique will be analysed using data collected at the time of device insertion and from subjects’ electronic medical records.
Intervention code [1] 323699 0
Treatment: Other
Comparator / control treatment
The control group is access gained via the subclavian vein (SCV). This is the current standard technique for central venous access in trauma resuscitation at the study site. SCV access is a landmark based technique and does not use ultrasound guidance.

The subclavian vein access technique involves gaining initial venous access to the subclavian vein using the landmarks of the deltopectoral triangle, and inserting the needle 2cm below the clavicle lateral to the supero-lateral border of the pectoralis major aiming towards the sternal notch. Once initial access is gained, the central venous catheter is inserted.

The same central venous catheter will be used for both groups. The only difference will be the site of access and use of ultrasound for RBCVO access.
Control group
Active

Outcomes
Primary outcome [1] 331546 0
Success rates associated with gaining central venous access. This is collected from a secure online REDCAP form the operator fills out following attempting central venous access.
Timepoint [1] 331546 0
Interim safety review following every 10 recruitments, and overall at conclusion of the study.
Primary outcome [2] 331547 0
Complication rates associated with gaining central venous access. This is collected from a secure online REDCAP form the operator fills out following attempting central venous access, from subjects' electronical medical records and from a secure online form available for any staff associated with patient care to report a complication.
Timepoint [2] 331547 0
Interim safety review following every 10 recruitments, and overall at conclusion of the study.
Secondary outcome [1] 410226 0
Procedural difficulty of gaining central venous access in shocked trauma resuscitation. Collected from a 5 point Likert scale as part of the secure online form filled out by the operator following attempting to gain ventral venous access ( Very Easy - Easy - Moderate - Difficult - Very Difficult)
Timepoint [1] 410226 0
Conclusion of study period

Eligibility
Key inclusion criteria
Participants will be selected if they have serious injuries and if the treating clinician has concern that the patient is shocked or is at risk of developing shock, and central venous access is needed within the first 30 minutes of arrival to the Alfred Emergency and Trauma Centre.
Participants include patients who:
- Have required blood products prehospital or during trauma reception
- Are expected to have ongoing blood loss
- Have a Shock Index (heart rate divided by systolic blood pressure, used as an indicator of haemorrhagic shock) of 1 or greater upon arrival
- Require central venous access for CT contrast injection, central venous pressure monitoring or ongoing care

Ethics approval for enrolment has been granted with a waiver of consent under the provisions of the Victorian Medical Treatment Decision Act 2016 .

Clinicians involved in this study are Trauma, Emergency and Anaesthesia consultants who are experienced with both landmark based subclavian vein central venous access, and ultrasound guided central venous access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded to this study if:
- No clinical concern that the patient is shocked
- Patient has an injury involving the RBCV
- No clinical need for central access
- No clinicians trained in the RBCVO access technique are available to insert the access device
- The origin of the RBCV cannot be clearly visualised with ultrasonography (e.g due to body habitus, wounds to the neck, subcutaneous emphysema or altered anatomy)
- Age of less than 18 years


Clinicians were not involved in this study if they were not Trauma, Emergency or Anaesthesia consultants who were experienced with both landmark based subclavian vein access and ultrasound guided central venous access techniques. Clinicians who did not undergo training in RBCVO access cannot recruit for this study.

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)
Sequential, sealed, opaque envelopes were used.
Randomisation was performed by an independent researcher to those involved in patient recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Data will be analysed using Stata BE, version 17. Success rates, complication rates and the rate of use of the RBCV origin access technique will be calculated.
The RBCVO access cohort will be compared to the SCV access cohort. Two tailed T-tests will be performed for numerical variables, and chi-squared for categorical variables.

A power calculation to determine sample size was not required for this feasibility study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/01/2023
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
50
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22475 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 37708 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 311283 0
Other
Name [1] 311283 0
National Trauma Research Institute
Country [1] 311283 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 316590 0
None
Name [1] 316590 0
Address [1] 316590 0
Country [1] 316590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310790 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 310790 0
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 310790 0
Australia
Date submitted for ethics approval [1] 310790 0
01/06/2022
Approval date [1] 310790 0
12/08/2022
Ethics approval number [1] 310790 0
312/22

Summary
Brief summary
Hypovolemic shock due to blood loss, known as haemorrhagic shock, is the most common cause of preventable death after injury. Principles of managing haemorrhagic shock include haemorrhage control and replacing the lost circulating blood volume. This requires venous access, which is a fundamental aspect of trauma resuscitation. In shocked trauma patients, obtaining venous access can be difficult and there are limitations to current methods of obtaining peripheral and central venous access. This project will investigate the use of the brachiocephalic veins for venous access in the resuscitation of shocked adult trauma patients.

The origin of the brachiocephalic veins is currently used for venous access in adult and paediatric populations, there is no published literature on what happens to the brachiocephalic veins in shock and the use of the brachiocephalic veins for access in shocked adult trauma patients. The Right Brachiocephalic Vein has been found to be preferable for access in adult patients may stabilised by the surrounding anatomical structure which could prevent vascular collapse collapse in severe shock.

If Right Brachiocephalic Vein origin access is found to be feasible in shocked trauma patients, it will provide a new access route for use during trauma resuscitation. This may improve venous access in patients with peripheral circulatory collapse, allowing for earlier replacement of lost blood volume using fluids and blood products. Additionally, vasoactive drugs can be given, and coagulopathies can be corrected earlier in resuscitation. This is vital in managing haemorrhagic shock and may improve patient outcomes. Hence, venous access using the origin of the Right Brachiocephalic Vein may improve resuscitation and decrease preventable deaths after injury due to haemorrhage.

The aim of this prospective randomised control trial is to prospectively evaluate the RBCVO central venous access technique in adult trauma patients to determine if the technique is appropriate for access in the trauma resuscitation setting., by comparing it to SCV access. This will include analysis of complications, success rates, efficacy and accuracy.

The research question of this study is:
How successful is RBCV origin access for the resuscitation of adult trauma patients?

The objectives of this study are to:
1. Determine the efficacy of RBCVO access in adult trauma resuscitation
2. Determine the safety of and complications associated with RBCVO access compared to SCV access.
3. Determine how appropriate RBCVO access is for the trauma resuscitation setting.


We hypothesize that vascular access using the origin of the RBCVO will be greater than 90% successful in adult major trauma patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118874 0
Prof Mark Fitzgerald
Address 118874 0
National Trauma Research Institute
Level 4/89 Commercial Rd, Melbourne VIC 3004
Country 118874 0
Australia
Phone 118874 0
+61418518094
Fax 118874 0
Email 118874 0
[email protected]
Contact person for public queries
Name 118875 0
Madeline Green
Address 118875 0
National Trauma Research Institute
Level 4/89 Commercial Rd, Melbourne VIC 3004
Country 118875 0
Australia
Phone 118875 0
+61491964357
Fax 118875 0
Email 118875 0
[email protected]
Contact person for scientific queries
Name 118876 0
Madeline Green
Address 118876 0
National Trauma Research Institute
Level 4/89 Commercial Rd, Melbourne VIC 3004
Country 118876 0
Australia
Phone 118876 0
+61491964357
Fax 118876 0
Email 118876 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
Individual not available due to privacy reasons. Group data will be made available on request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19852Ethical approval    383954-(Uploaded-01-08-2023-14-29-40)-Study-related document.pdf



Results publications and other study-related documents

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