The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Time weighed average of hypotension below 65 mmHg
研究概览
简要总结
The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery.
Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index.
The main question the study aims to answer is:
• will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.
详细描述
The fundamental aspect of the anesthetics perioperative management is to maintain hemodynamic stability, with special attention on the avoidance or reduction of the episodes of intraoperative hypotension (IOH). The incidence of intraoperative hypotension is related to an increased rate of perioperative morbidity and mortality. Even a short period of hypotension can be related to an increased risk of postoperative stroke, myocardial injury and acute kidney injury. Patients undergoing major abdominal surgery are at a high-risk of IOH because such surgeries typically require more than 2h to complete and require blood transfusion or inotrope administration. Hemodynamic monitoring and the use of goal directed therapy protocols helps to diminish the incidence of perioperative complications, however the hypotension management remains a reactive approach, an intervention is made when the hypotension has already occured. The Hypotension Prediction Index is an machine learning algorithm which allows to predict the episodes of hypotension and intervene before mean arterial pressure drops below 65 mmHg. The aim of the current study is to compare the rate of hypotension in patients undergoing major abdominal surgery with the arterial pressure cardiac output algorithm and the hypotension prediction index algorithm.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of >15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia.
- •Patients with American Society of Anesthesiologists (ASA) status III or IV.
- •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 cardiac output monitoring
结局指标
主要结局
Time weighed average of hypotension below 65 mmHg
时间窗: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
depth of hypotension in millimetres of mercury below a mean arterial pressure (MAP) of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
次要结局
- Intraoperative vasopressor dose("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Rate of intra and postoperative atrial fibrillation("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Kidney injury evaluated by creatinine levels(First, second and fifth postoperative day)
- Intraoperative fluid dose("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Time weighed average of hypotension below 50 mmHg("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Time weighed average of hypertension above 90 mmHg("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Time weighed average of hypertension above 100 mmHg("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- 30 day mortality(30 consecutive days starting from the day of the surgery)
- Length of hospitalisation(From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days)
- Myocardial injury evaluated by postoperative troponin levels(First, second and fifth postoperative day)
- Time weighed average of hypotension below 50 mmHg("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Time weighed average of hypertension above 90 mmHg("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Time weighed average of hypertension above 100 mmHg("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- 30 day mortality(30 consecutive days starting from the day of the surgery)
- Length of hospitalisation(From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days)
- Myocardial injury evaluated by postoperative troponin levels(First, second and fifth postoperative day)
- Kidney injury evaluated by creatinine levels(First, second and fifth postoperative day)
- Intraoperative fluid dose("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Intraoperative vasopressor dose("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
- Rate of intra and postoperative atrial fibrillation("From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days)
研究者
Jakub Szrama
Principal Investigator
Poznan University of Medical Sciences