The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- TWA Mean Arterial Pressure (MAP) < 65 mmHg
研究概览
简要总结
The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The studied patients will be blinded to the enrolled group.
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 qualified to head and neck free flap surgery
- •Written informed consent
排除标准
- •Patients under 18 years
- •Lack of health insurance
- •Pregnancy
- •Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
- •Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring
结局指标
主要结局
TWA Mean Arterial Pressure (MAP) < 65 mmHg
时间窗: From the beginning of the anesthesia to the end of anesthesia
TWA - MAP \< 65 mmHg - time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
次要结局
- TWA - MAP < 55 mmHg(From the beginning of the anesthesia to the end of anesthesia)
- TWA - MAP < 60 mmHg(From the beginning of the anesthesia to the end of anesthesia)
- 30 day mortality(30 days)
- Length of hospitalisation(From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months)
研究者
Jakub Szrama
Principal Investigator
Poznan University of Medical Sciences