None listed
Conditions
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.
Interventions
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
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.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed