Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean Total Blood Loss
研究概览
简要总结
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The participants and investigator will be blind to participant treatment group assignment. Only the research coordinator will know treatment group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Volta tAN System (Device)
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.
干预措施: SHAM Volta tAN System (Device)
结局指标
主要结局
Mean Total Blood Loss
时间窗: Throughout procedure
Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.
次要结局
- Surgery Time(First incision to incision closure)
- Time to Hemostasis(From end of AV graft placement to beginning of surgical site closure)