The Use of the Hypotension Prediction Index (HPI) Combined With the Assisted Fluid Management (AFM) Software for Perioperative Hemodynamic Optimization in Patients Undergoing General Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time-weighted average of intraoperative hypotension
研究概览
简要总结
This study investigates if the Hypotension Prediction Index (HPI) combined with the Assisted Fluid Management (AFM) software can improve perioperative hemodynamic management in adult patients undergoing general anesthesia. The main question is :
Does the HPI and AFM software reduce the incidence and duration of intraoperative hypotension? Does the HPI and AFM software optimize fluid and vasopressor administration? Does the HPI and AFM software improve perioperative outcomes? Participants will be randomly allocated to either an experimental group receiving goal directed hemodynamic therapy guided by HPI and AFM or a control group receiving conventional hemodynamic management.
详细描述
Intraoperative hypotension is a common complication during general anesthesia and is associated with an increased risk of postoperative organ dysfunction (acute kidney injury, myocardial ischemia). Even short episodes of mean arterial pressure (MAP) below accepted thresholds have been shown to adversely affect patient outcomes.
The Hypotension Prediction Index , (HPI)is a software that predicts the likelihood of hypotension minutes before it occurs, based on the arterial waveform. Thus clinicians have the opportunity to identify patients at risk of hypotension and intervene early.
The Assisted Fluid Management (AFM) software is designed to optimize perioperative fluid administration based on the Frank-Starling curve. The AFM provides guidance on crystalloid admininistration only when it is expected to increase stroke volume and cardiac output.
This prospective , randomized study evaluates whether the use of HPI coupled with AFM within a goal directed hemodynamic protocol improves perioperative hemodynamic management and reduces the incidence and duration of adult patients undergoing surgery under general anesthesia.
A total of 100 adult patients will be enrolled , for elective surgery with invasive blood pressure monitoring and intraoperative mean arterial pressure target of at least 65 mm Hg.
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
- None
盲法说明
Clinicians managing patients are aware of group assignment, as treatment decisions depend on the intervention. Outcome assessors collect data but do not influence group allocation.
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
- •Age > 18 years
- •Intraoperative monitoring > 2 hours or general anesthesia > 2 hours
- •Invasive arterial pressure monitoring
- •Target MAP ≥ 65 mm Hg intraoperatively
- •Written informed consent preoperatively
- •ASA Physical Status ≤ 4
排除标准
- •Target MAP other than 65 mm Hg
- •Severe preoperative hypotension (MAP < 65 mm Hg)
- •Severe heart failure (e.g. LVEF < 20%)
- •Emergency surgery
研究组 & 干预措施
HPI/AFM - Goal- Directed Hemodynamic Therapy
Participants will receive goal-directed hemodynamic therapy guided by the Hypotension Prediction Index and Assisted Fluid Management software, using the Hemosphere monitor.
Interventions include protocol-guided fluid and vasopressors to prevent or treat intraoperative hypotension.
干预措施: Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software (Device)
Conventional therapy
Participants will receive conventional hemodynamic intraoperative management based on anesthesiologist's clinical judgement. The Acumen IQ sensor will be placed but Hypotension Prediction Index and Assisted Fluid Management outputs will not be visible to the anesthesiologist.
干预措施: Conventional Intraoperative Hemodynamic management (Other)
结局指标
主要结局
Time-weighted average of intraoperative hypotension
时间窗: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation
Time weighted average spent in hypotension, defined as mean arterial pressure (MAP) \<65mmHg for ≥ 1min, measures using the Acumen IQ sensor and Hemosphere monitor.
次要结局
- Incidence of hypotension(Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation)
- Time spent in hypotension(Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation)
- Choice of therapy (fluids/medications)(Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation)
- Dose of therapy (fluids/medications)(Intraoperatively, starting 15 minutes after anesthesia induction.)
- Protocol deviations(Intraoperatively, starting 15 minutes after anesthesia induction)
研究者
NTALAMAGKA GEORGIA
Principal Investigator
Attikon Hospital