The Effect of Perioperative Cardiac Output-guided Goal-directed Hemodynamic Therapy (GDT) on Perioperative Oxygen Delivery, Consumption, and Microcirculatory Perfusion in Comparison to Routine Hemodynamic Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Perioperative changes in oxygen consumption
研究概览
简要总结
Perioperative cardiac output-guided goal-directed therapy (GDT) triggers fluid, vasopressor, and inotrope administration assuming that optimizing cardiac output (i.e., global blood flow) ensures adequate oxygen delivery and microcirculatory perfusion - that are usually not directly monitored during goal-directed therapy. There is increasing evidence that perioperative cardiac output-guided goal-directed therapy may reduce postoperative complications compared to routine hemodynamic management in high-risk patients having major surgery. The effect of cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as microcirculatory perfusion, however, is unknown.
The investigators aim to investigate the effect of using different cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as sublingual microcirculatory perfusion compared to routine perioperative hemodynamic management in patients having major abdominal surgery with general anesthesia.
详细描述
Perioperative cardiac output-guided goal-directed therapy (GDT) triggers fluid, vasopressor, and inotrope administration assuming that optimizing cardiac output (i.e., global blood flow) ensures adequate oxygen delivery and microcirculatory perfusion - that are usually not directly monitored during goal-directed therapy. There is increasing evidence that perioperative cardiac output-guided goal-directed therapy may reduce postoperative complications compared to routine hemodynamic management in high-risk patients having major surgery. The effect of cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as microcirculatory perfusion, however, is unknown.
With technological advancements a distinct monitoring of oxygen delivery and consumption as well as microcirculatory perfusion in the perioperative period has become possible. Using new technologies, a detailed understanding of the effect of cardiac output-guided goal-directed therapy on perioperative oxygen delivery and consumption as well as microcirculatory perfusion is of vital importance to further develop and improve perioperative hemodynamic treatment strategies.
In this pilot randomized-controlled trial, the investigators therefore aim to investigate the effect of using different cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as sublingual microcirculatory perfusion compared to routine perioperative hemodynamic management in patients having major abdominal surgery with general anesthesia.
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 (Outcomes Assessor)
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
- •Adult patients (≥18 years) having elective major abdominal surgery with general anesthesia
- •Expected duration of surgery at least 120 minutes
- •Planned postoperative monitoring in intensive care unit
排除标准
- •Emergency surgery
- •Age <18 years
- •Body weight <50 kg
- •Pregnancy
- •Atrial fibrillation
- •Planned patient positioning in other position than supine position
- •Surgery within the last 30 days
- •Inaccessibility of the head during surgery
- •Peripheral artery disease stage ≥IIb
- •Chronic vasculitis
- •Supraglottic airway management
- •Enterostomy repair surgery
研究组 & 干预措施
Cardiac output maximization group
Patients will be treated according to a goal-directed therapy protocol aiming at a cardiac output maximization.
Detailed protocol adapted from Edwards, M.R., et al., Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery. BMJ Open, 2019. 9(1): p. e023455.
干预措施: Treatment algorithms targeting cardiac output (Other)
Cardiac output personalization group
Patients will be treated according to a goal-directed therapy protocol aiming at a personalized cardiac output goal determined with preoperative cardiac output assessment.
Detailed protocol adapted from Nicklas, J.Y., et al., Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth, 2020. 125(2): p. 122-132.
干预措施: Treatment algorithms targeting cardiac output (Other)
Routine management group
Patients will be treated according to routine hemodynamic management.
结局指标
主要结局
Perioperative changes in oxygen consumption
时间窗: baseline awake, after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery
assessed via indirect calorimetry
Perioperative changes in oxygen delivery
时间窗: after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery
assessed via blood gas analysis
次要结局
- Perioperative changes of microcirculation(baseline awake, after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery)
- Perioperative changes in cardiac output(baseline awake, after induction of general anesthesia, during the last 30 minutes of surgery, within 6 hours after surgery, day 1, 2, 3 after surgery)