The Neuralert Stroke Monitor Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time to Nursing Response
研究概览
简要总结
This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, integration into clinical workflow, usability and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥ 22 years
- •Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
- •Considered at high risk for stroke while in the hospital based on:
- •Ø Interventions or procedures that are high-risk for stroke performed during the hospitalization, which may include:
- •Intracardiac surgical or endovascular procedures, including valve replacement
- •Ascending aorta or aortic arch surgical or endovascular repair
- •Open surgical or endovascular carotid revascularization
- •Ø Other cardiac procedures along with a high-risk medical history:
- •Age ≥ 80 years · Prior stroke/TIA
- •Hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation
- •Severely reduced left ventricular cardiac ejection fraction (i.e., <30%) or anterior left ventricular wall akinesis
- •Atrial fibrillation
- •Admitted with a stroke or TIA attributed to large artery occlusion or severe stenosis that has not been revascularized.
排除标准
- •(all must be no)
- •Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- •Baseline preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity motor score between the two arms of >0
- •Above the wrist amputation
- •Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
- •Currently imprisoned
结局指标
主要结局
Time to Nursing Response
时间窗: Up to 5 days post patient surgery
The time from the nurse receiving an alert to the time they respond after assessing the patient.
Time to Generate Alert
时间窗: Up to 5 days post patient surgery
The time to successful generation of an alert to staff when asymmetry or low battery is detected.
次要结局
- Number of Strokes Identified(Up to 5 days post patient surgery)
- Device Tolerability(Up to 5 days post patient surgery)