HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- TWA hypotension (measured with FlotracIQ)
研究概览
简要总结
Reducing intraoperative hypotension using FlotracIQ with HPI software.
详细描述
Intraoperative hypotension occurs often. Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. Currently treatment of these hypotensive episodes is not proactive. Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours
- •Planned to receive general anaesthesia
- •Planned to receive an arterial line during surgery
- •Aim for MAP of 65 mmHg during surgery
- •Being able to give written informed consent prior to surgery
排除标准
- •Aim for MAP other than 65 mmHg at discretion treating physician
- •Significant hypotension before surgery defined as a MAP <65
- •Right- or left sided cardiac failure (e.g. LVEF<35%)
- •Known cardiac shunts (significant)
- •Known aortic stenosis (severe)
- •Severe cardiac arrhythmias including atrial fibrillation
- •Requiring dialysis
- •Liver surgery
- •Vascular surgery with clamping of the aorta
- •Perioperative Goal Directed Therapy (PGDT) protocol
研究组 & 干预措施
Conventional arm
Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered.
Treatment arm
FlotracIQ with HPI algorithm.
干预措施: FlotracIQ with HPI algorithm (Device)
结局指标
主要结局
TWA hypotension (measured with FlotracIQ)
时间窗: intraoperative, starting 15 minutes after induction
Time weighted average spent in hypotension, defined as MAP \<65mmHg for ≥1min
次要结局
- TWA hypertension (measured with FlotracIQ)(intraoperative, starting 15 minutes after induction)
- Incidence of hypotension (measured with FlotracIQ)(intraoperative, starting 15 minutes after induction)
- Treatment choice (CRF, EPD)(intraoperative, starting 15 minutes after induction)
- Time to treatment (CRF)(intraoperative, starting 15 minutes after induction)
- Time spent in hypotension (measured with FlotracIQ)(intraoperative, starting 15 minutes after induction)
- Incidence of hypertension (measured with FlotracIQ)(intraoperative, starting 15 minutes after induction)
- Percentage of time in hypertension (measured with FlotracIQ)(intraoperative, starting 15 minutes after induction)
- Diagnostic guidance protocol deviations (CRF)(intraoperative, starting 15 minutes after induction)
- Treatment dose (CRF, EPD)(intraoperative, starting 15 minutes after induction)
研究者
D.P.Veelo
Principal Investigator, Medical Doctor, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)