Transcutaneous Auricular Vagus Nerve Stimulation for Attenuation of Inflammatory Response and Blood Pressure in Type B Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Role of taVNS on serum CRP
研究概览
简要总结
Patients with uncomplicated Type B aortic dissections (TBAD) are traditionally treated in the ICU for impulse control, with BP and HR goals. Local and systemic inflammation often is a resulting consequence of acute aortic dissection. Vagus nerve stimulation can impact hemodynamics and inflammation. This study will utilize a novel transcutaneous auricular vagus nerve stimulator (taVNS) as part of the treatment for patients with TBAD. It's hypothesized that vagus nerve stimulation may provide benefit to the acute TBAD population admitted to ICU by two distinct mechanisms:
- Through upregulation of parasympathetic pathways which may augment chemical heart rate and blood pressure control through bioelectric stimulation, and
- downregulation of inflammatory pathways through a neuro-immunological axis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 years and older.
- •Presenting with acute, uncomplicated TBAD
- •Ability to enroll within 24 hours of presentation
排除标准
- •Prior Aortic Dissections
- •Genetic aortpathies
- •Iatrogenic aortic dissection related to prior procedure(s)
研究组 & 干预措施
Treatment Cohort
The treatment cohort will undergo transcutaneous auricular nerve stimulation using an in-house 3D printed earpiece fitted with an off-the-shelf stimulation device
干预措施: 3D Printed Earpiece (Device)
Treatment Cohort
The treatment cohort will undergo transcutaneous auricular nerve stimulation using an in-house 3D printed earpiece fitted with an off-the-shelf stimulation device
干预措施: Auricular Vagus Nerve Stimulator (Device)
Nontreatment Cohort
The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered.
干预措施: 3D Printed Earpiece (Device)
结局指标
主要结局
Role of taVNS on serum CRP
时间窗: Day 1, 3, 7, and 14 should the patient still be admitted.
Identify if taVNS can change serum CRP over 2 weeks in patients with acute type B aortic dissections.
Role of taVNS on dissection related end-organ deficits
时间窗: through study completion, an average of 1 year
Identify if in the acute period (2 weeks) following type B aortic dissections, if taVNS can change the incidence of mesenteric, renal, and limb-related ischemic events
次要结局
- Role of taVNS in mitigation of dissection propagation or evolution(Day 3, Day 30)
- Role of taVNS in surgical intervention rates(Up to 2 weeks)
- Role of taVNS in impulse control dosing(Up to 2 weeks)
- Role of taVNS in ICU and hospital length of stay(Treatment to hospital discharge, expected to occur, on average, between 1-2 weeks from admission/initial treatment)
- Role of taVNS in the healthcare economics(Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter)