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临床试验/NCT03965702
NCT03965702已完成不适用

Impact of a Real Time Clinical Decision Support System to Guide Fluid Administration on Microvascular Parameters in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年12月13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
86
试验地点
2
主要终点
Microvascular flow index

研究概览

简要总结

This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Life sciences, Irvine, USA) to a group of patients managed using a novel real time clinical decision support system for goal directed fluid therapy (GDFT) guidance on microvascular parameters in patients undergoing major abdominal or orthopedic surgery.

详细描述

Many trials have indicated that GDFT strategies may benefit high-risk surgical patients but these strategies are infrequently implemented on a day to day basis. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist and have been correlated with marked variations in patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation.Haemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention.

To address this problem of consistency and protocol adherence, a novel real time clinical decision support system, "Assisted Fluid Management" (AFM), has been designed to help ease some of the workload associated with GDFT protocol implementation. The AFM system (released on the European market in March 2017) may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This system can suggest fluid bolus administration, analyse the effects of the bolus, and continually re-assess the patient for further fluid requirements.

Mean arterial pressure will be at least maintained in both groups above 65 mmHg with norepinephrine administration. Vasopressors administration is standardised in both groups (objective is a MAP of > 65 mmHg) and the only difference will be the way fluid boluses are given to the patient (following standard of care (manual protocol) of following the assisted fluid management recommandations)

A recent published study demonstrated that the implementation of the AFM for GDFT guidance resulted in a significantly longer period during surgery in a preload independent state (defined as a SVV < 13%) with a reduced total amount of fluid administered without any difference in postoperative complications.

Another recent study demonstrated that during abdominal surgery, microvascular perfusion is impaired during preload dependence (SVV >13%) and recovers after fluid administration (preload independent state)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

All microvascular parameters will be analyzed at the end of the study by a blinded physicians (not linked to the study and not author of the future manuscript)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients in the operating room scheduled for a major abdominal & orthopedic surgery requiring a cardiac output monitoring (EV1000).
  • Written informed consent received before surgery.

排除标准

  • Minor Patients.
  • No french speaking.
  • Atrial fibrillation or severe arrythmia.

结局指标

主要结局

Microvascular flow index

时间窗: Day 0

Comparison of this index between groups during the intraoperative period. The image is divided into four quadrants and the predominant type of flow in very small vessels is assessed in each quadrant using an ordinal score (0= no flow; 1 = intermittent flow; 2 = sluggish flow; 3 = normal flow). The overall score, called microvascular flow index, is the sum of each quadrant score divided by the number of quadrants

次要结局

  • Cardiac output over the procedure(Postoperative day 1)
  • Total Fluid received during the procedure(Postoperative day 1)
  • Proportion of perfused vessels(Day 0)
  • Heterogeneity index(Day 0)
  • Composite criteria of major postoperative complications(30 days postsurgery)
  • Composite criteria of minor postoperative complications(30 days postsurgery)
  • Stroke volume over the procedure(Postoperative day 1)
  • Hospital length of stay(30 days postsurgery)
  • Net fluid balance(Postoperative day 1)
  • minimal value of microvascular flow index(Day 0)
  • Perfused vessel density(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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