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临床试验/NCT05090254
NCT05090254已完成不适用

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

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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