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临床试验/NCT02826889
NCT02826889已完成不适用

Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table

Yonsei University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Pleth Variability Index (PVI)

研究概览

简要总结

Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •1. Patients between the age of 19 and 75, scheduled for spine surgery under general anesthesia using the Jackson table

排除标准

  • •Patient refusal
  • •Patients that are not normal sinus rhythm on preoperative ECG
  • •Patients with moderate~severe cardiac valve disease
  • •Patients with an ejection fraction under 50%
  • •Significant lung disease
  • •Obesity (BMI>35kg/m2)
  • •Patients with contraindications to esophageal doppler probe insertion
  • •Illiterate patients or foreigners

研究组 & 干预措施

Fluid loading group

Experimental

干预措施: Philips Intelivue MP70 monitor (Device)

Fluid loading group

Experimental

干预措施: Pleth Variability Index (PVI) (Device)

结局指标

主要结局

Pleth Variability Index (PVI)

时间窗: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position

Pulse Pressure Variation (PPV)

时间窗: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position

Fluid responsiveness predictability of FTc and PVI in patients undergoing posterior lumbar fusion in the prone position by using the Jackson frame by calculating area under the curve of the ROC curve.

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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