Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
University Surgical Vascular
Summary
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
Description
This study is designed as a randomized, double-blind, sham-controlled, single-center, pilot clinical trial in which adults undergoing dialysis port placement procedures will be randomized 1:1 into one of two treatment groups: Group 1: Active tAN + standard of care Group 2: Sham tAN + standard of care Participants will receive 30 minutes of active or sham tAN immediately prior to the dialysis port placement procedure. Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is undergoing a dialysis port placement procedure using synthetic graft * Participant is between 18 and 75 years of age * Participant is English proficient * Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements Exclusion Criteria: * Participant has a BMI ≥ 40 * Participant is currently taking a platelet inhibitor medication * Participant has a history of epileptic seizures * Participant has a history of neurological diseases or traumatic brain injury * Participant has presence of devices, e.…
Interventions
- DeviceVolta tAN System
Transcutaneous auricular neurostimulation (tAN)
- DeviceSHAM Volta tAN System
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.
Location
- University Surgical VascularWatkinsville, Georgia