Vitalstream Gold Standard Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- BP Reading Agreement
研究概览
简要总结
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard.
详细描述
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard, either an arterial line or an upper arm cuff, to assess the capabilities and limitations of the technology. Specifically, the objective is to demonstrate the Vitalstream's ability to adhere to the limits prescribed by ANSI/AAMI/ISO 81060-2:2019 as closely as possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients 18 years of age or older having the following surgery or procedures Electrophysiology Lab patients undergoing ablation Cardiac Catheterization Lab patients undergoing heart catheterization Cardiac Surgery patients including CABG and/or cardiac valve repair/replacement Abdominal Surgery patients including hepatectomy, pancreatectomy, and gastrectomy
排除标准
- •Patients less than 18 years of age Patients with any pre-existing finger or hand injury which will preclude the placement of the Caretaker finger blood pressure cuff
研究组 & 干预措施
Cooper Union patients
OR, ICU, EP-Lab, Cath-lab patients
干预措施: Vitalstream (Device)
结局指标
主要结局
BP Reading Agreement
时间窗: 30 minutes to 24 hours
BP reading agreement according to ISO 81060 standard
时间窗: 30 minutes to 24 hours
BP reading agreement according to ISO 81060 standard
次要结局
未报告次要终点