Blood Loss, Surgical
Conditions
Keywords
auricular neurostimulation, vagus nerve stimulation, transcutaneous, blood loss, transcutaneous auricular neurostimulation, tAN
Brief 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.
Detailed 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.
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.
Sponsors
University Surgical Vascular
Spark Biomedical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The participants and investigator will be blind to participant treatment group assignment. Only the research coordinator will know treatment group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.g., pacemakers, cochlear prosthesis, neurostimulators * Participant has abnormal ear anatomy or ear infection present * Person of childbearing age, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study * Person who is pregnant or lactating * Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Blood Loss | Throughout procedure | Comparison of mean total quantified blood loss in active tAN versus sham tAN groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Time | First incision to incision closure | Surgery time measured as total time from first incision to incision closure in active tAN versus sham tAN groups. |
| Time to Hemostasis | From end of AV graft placement to beginning of surgical site closure | Comparison of mean time to hemostasis in active tAN versus sham tAN groups. |
Countries
United States
Contacts
CONTACTDavid Sailors, MD
Outcome results
None listed