The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Transcutaneous auricular neurostimulation (tAN)
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.
University Surgical Vascular
Watkinsville, Georgia, United States
Mean Total Blood Loss
Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.
Time frame: Throughout procedure
Surgery Time
Surgery time measured as total time from first incision to incision closure in active tAN versus sham tAN groups.
Time frame: First incision to incision closure
Time to Hemostasis
Comparison of mean time to hemostasis in active tAN versus sham tAN groups.
Time frame: From end of AV graft placement to beginning of surgical site closure
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