Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures

Conditions

Volta tAN System — DEVICE
Transcutaneous auricular neurostimulation (tAN)
SHAM Volta tAN System — DEVICE
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.

The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.

Experimental: Active tAN + standard of care
Participants randomized to the active group will have an earpiece applied and receive 30 minutes of active tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed.
Sham Comparator: Sham tAN + standard of care
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on. These participants will receive 30 minutes of sham tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed.

Mean Total Blood Loss [ Time Frame: Throughout procedure ]

Facility	City	State	ZIP	Site coordinators
University Surgical Vascular	Watkinsville	Georgia	30677	David Sailors, MD David Sailors, MD (PRINCIPAL_INVESTIGATOR)

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