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临床试验/NCT04298931
NCT04298931已完成不适用

Fluid Responsiveness Prediction Using Pulse Pressure Variation - Integrating Ventilator Settings

University of Aarhus1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年5月15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
52
试验地点
1
主要终点
>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)

研究概览

简要总结

It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest.

Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration.

However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable.

The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Scheduled open abdominal surgery.
  • Scheduled treatment with Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).

排除标准

  • Left ventricular ejection fraction ≤ 40 %
  • Irregular heart rhythm (e.g. atrial fibrillation or frequent ectopic beats)
  • Known right ventricular dysfunction (if reported qualitatively in pre-operative assessment or objectively via Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 mm)
  • Pregnancy
  • Prior participation in this study

结局指标

主要结局

>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)

时间窗: From two minutes before to two minutes after a fluid administration.

A patient is considered a fluid responder if they have a \>10% increase in stroke volume (pulse contour analysis by the Edwards EV1000 with a FloTrac sensor). Pre-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately preceding the fluid bolus. Post-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately following the fluid bolus. Change in stroke volume is calculated as: 100% \* (Post-fluid stroke volume - Pre-fluid stroke volume) / Pre-fluid stroke volume

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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