Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Perioperative blood pressure
研究概览
简要总结
This is a single centre, prospective, non-randomised clinical investigation to be undertaken at the Queen Elizabeth Hospital, Edgbaston, Birmingham.
The clinical investigation will collect fully anonymised perioperative blood pressure data from patients undergoing elective high risk surgery.
The Sponsor of this clinical investigation, Directed Systems Limited, is developing a new medical device, BP Assist, which provides guidance to anaesthetists in relation to the real-time management of patient cardiovascular physiology.
详细描述
This clinical investigation is designed to collect fully anonymised perioperative blood pressure data from patients undergoing high risk surgical procedures.
It is increasingly being recognised that in high risk surgery, the perioperative incidence and duration of hypotensive episodes (MAP <60mmHg) can adversely impact postoperative outcome.
Collecting continuous perioperative blood pressure data will enable hypotensive episodes to be recorded. Such data will be used to aid the development and testing of algorithms involved in generating the guidance provided by BP Assist.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female, 18 years of age or older; undergoiing elective high risk surgery
排除标准
- •<18 years of age
结局指标
主要结局
Perioperative blood pressure
时间窗: Duration of each patient's surgery, up to 6 hours.
The primary objective of this clinical investigation is to collect fully anonymised, continuous, perioperative blood pressure data from ten patients undergoing elective high-risk surgery. Systolic and mean arterial pressures will be recorded.
次要结局
未报告次要终点