Feasibility Study of E-Fusion Vasopressor Titration-Assist as a Clinical Decision Support Tool During Multi-Level Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of adverse events and serious adverse events of relevance attributed to E-Fusion
研究概览
简要总结
This is a single-arm feasibility study of E-Fusion Vasopressor Titration-Assist, a clinical decision support software, in 10 adults undergoing multi-level spine surgery. E-Fusion monitors blood pressure from the patient monitor and displays recommended changes to the norepinephrine infusion rate. The anesthesia provider independently reviews each recommendation and may accept or ignore it. The software does not connect to or control the infusion pump. The primary objective is to assess safety by evaluating adverse events attributable to E-Fusion during surgery. Secondary objectives evaluate clinician agreement with the recommendations and blood pressure management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age 22 years or older
- •Patient or a legally authorized representative (LAR) has provided written informed consent
- •Patient is expected to receive norepinephrine through a central line, PICC line, or peripheral line for blood pressure management
- •Patient's blood pressure is monitored with an arterial line
- •Patient is undergoing multi-level spine surgery with an expected duration of at least 2 hours and not exceeding 8 hours
排除标准
- •Confirmed pregnancy and/or nursing mothers
- •Currently participating in another interventional study
- •Patients who are likely to bleed excessively and/or need rapid transfusion
- •Patients expected to be disconnected and transported for imaging during the study procedure
- •History of cardiac arrhythmias
- •Patients receiving another actively titrated vasopressor during study (excluding vasopressin)
研究组 & 干预措施
E-Fusion clinical decision support
All subjects receive standard anesthetic care. E-Fusion displays advisory norepinephrine infusion rate recommendations that the anesthesia provider may accept or ignore.
干预措施: E-Fusion Vasopressor Titration-Assist (Device)
结局指标
主要结局
Number of adverse events and serious adverse events of relevance attributed to E-Fusion
时间窗: Intraoperative period, from E-Fusion activation to deactivation or end of surgery, up to 8 hours
Number of adverse events (AEs) and serious adverse events (SAEs) of relevance occurring during surgery, attributed to E-Fusion based on clinician assessment, including major adverse cardiac events, intraoperative arrhythmia, and infusion-related injury.
次要结局
- Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider(Intraoperative period, up to 8 hours)
- Time-weighted average mean arterial pressure (TWA-MAP) above and below target(Intraoperative period, up to 8 hours)