The TAVERN Trial: Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU - A Study of Clinical Outcomes and Cost Reduction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Neurological outcome
研究概览
简要总结
This study will demonstrate the impact of taVNS on reducing adverse events in NeuroICU patients, determine if taVNS reduces length of stay, and quantify the economic benefits of taVNS implementation in a broader neurocritical care population.
详细描述
Vagal nerve stimulation (VNS) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. The purpose of the proposed study is to determine if transcutaneous auricular VNS will impact 1) the occurrence of hospital-acquired infections, 2) the need for tracheostomy due to prolonged intubation, 3) the effect on hospital-stay physiology (e.g., vital signs and blood glucose metrics), and 4) inflammatory markers in the blood, and 5) the health economics.
This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood samples for inflammatory marker analysis will be collected upon admission and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the occurrence of hospital-acquired infections, tracheostomy, changes in vital signs and blood glucose, development of peri-hematomal edema, and interventions for edema (medical or surgical). Outcomes following admission will include intensive care unit and hospital stay, cost analysis of hospital stay, discharge destination, functional scores at discharge, and at follow-up visits for up to 1 year after discharge. No additional appointments will be made specially for the research study.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores and measures will be assessed and recorded by clinicians and research team members blinded to the treatment arm.
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
- •Admission to the NeuroICU within 36 hours of onset of an acute medical condition.
- •Patient or authorized legal representative should be able to provide consent within 36 hours of ICU arrival
- •Presence of at least one predictor of critical illness and/or severe brain / spinal cord injury:
- •Glasgow Coma Scale GCS >3 & <= 12 at admission
- •NIH stroke scale of 6 or greater
- •Requirement for ongoing mechanical ventilation
- •Requirement for ongoing vasopressor support
- •Diagnosis of subarachnoid hemorrhage
- •Diagnosis of intracerebral hemorrhage with hematoma volume > 5 ml
- •Diagnosis of moderate-severe traumatic brain injury (GCS >3 & <= 12)
- •Refractory Status epilepticus requiring continuous sedative infusions
排除标准
- •Systemic immunosuppression
- •Receiving ongoing cancer therapy
- •Implanted electrical device (e.g., pacemaker, stimulator)
- •Bradycardia on admission (Sustained bradycardia on arrival with a heart rate < 50 bpm for >5 minutes)
- •Risk of imminent death or limitation of care (e.g., Glasgow Coma Scale of 3, pupillary dilatation)
- •Expected ICU stay of less than 72 hours, as determined by attending physician or ICU fellow
- •Pregnancy
研究组 & 干预措施
Auricular VNS Stimulation
Participants receive twice-daily auricular vagal nerve stimulation
干预措施: Auricular Vagus Nerve Stimulation (Device)
Sham Auricular VNS Stimulation
Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied
干预措施: Sham Auricular Vagus nerve Stimulation (Device)
结局指标
主要结局
Neurological outcome
时间窗: 1 year
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Assessment of the need for tracheostomy.
时间窗: 14 days
Quantification of patients who need tracheostomy due to prolonged intubation.
Cost of Hospital Admission
时间窗: Through hospital admission, average 14 days
Evaluation of total hospital admission cost of stay ($)
Occurrence of hospital-acquired infections
时间窗: 14 days
Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.
Changes in heart rate/heart trace
时间窗: 14 days
Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.
Blood glucose measurement
时间窗: 14 days
Daily evaluation of blood glucose (mg/dL)
Insulin requirement
时间窗: 14 days
Assessment of daily insulin requirement (Units)
Hospital length of stay
时间窗: Through hospital admission, average 14 days
Total length of stay in the hospital, and in the intensive care unit
Discharge destination
时间窗: After hospital discharge, on average 14 days after admission.
Patient discharge destination (ie, home, acute rehab)
Cost of ICU stay
时间窗: Through hospital admission, average 14 days
Evaluation of total ICU cost of stay ($)
次要结局
- Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma(14 days)
- Change in inflammatory markers in cerebrospinal fluid(14 days)
- Cerebral Edema(14 days)
- Neurological outcome at discharge and first follow-up(up to 1 year.)
- Neurological Outcome at discharge and first follow-up(Up to 1 year.)
- Neurological Outcome at discharge and first follow-up.(Up to 1 year.)
- Diagnosis of hospital-acquired infections(Through hospital admission, average 14 days)
- Use of a ventilator(Through hospital admission, average 14 days)
- Neurological Outcome at discharge and first follow-up(up to 1 year.)