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临床试验/NCT03009669
NCT03009669Unknown不适用

The Application of Pleth Variability Index in Continuous Monitoring Volume Status in Patients Undergoing Intestinal Tumor Surgery

First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 50 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
the correlation of SVV and PVI

研究概览

简要总结

To assess the value of using pleth variability index(PVI) to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor surgeries.

详细描述

Objective

To assess the value of using PVI to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and pleth variability index(PVI) and their correlation in patients undergoing intestinal tumor surgeries.

Methods: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ, aged 18-65 years. After the induction of general anesthesia, cardiac index(CI), cardiac output(CO), stroke volume variability(SVV), stroke volume index(SVI) were monitored with Vigileo system, while pleth variability index(PVI) and perfusion index(PI) were monitored with Massion Radical 7 system. During the surgery, goal directed fluid therapy was conducted according to the data of CI、SVI and SVV. Heart rate(HR), mean arterial pressure(MAP), central venous pressure(CVP), CO, CI, SVI, SVV, PI, PVI were recorded while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4). And we calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing elective intestinal tumor surgery
  • American Society of Anesthesiologists (ASA) physical status of grade I-Ⅲ
  • Aged 18-65 years
  • BMI 18~30kg/㎡

排除标准

  • Patients under 18 years or above 65 years
  • patients with severe aortic regurgitation
  • patients with permanent cardiac arrhythmias
  • patients with intra-aortic balloon pump
  • patients with severe pulmonary disease
  • patients undergoing emergency surgery

结局指标

主要结局

the correlation of SVV and PVI

时间窗: during the surgery

SVV and PVI were recorded while after the induction of anesthesia(T1),making surgical incision(T2),performing intestinal anastomosis(T3) and closing the abdominal incision(T4). We calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.

次要结局

  • pleth index(PI)(during the surgery)
  • cardiac index(CI)(during the surgery)
  • stroke volume index(SVI)(during the surgery)
  • stroke volume variability(SVV)(during the surgery)
  • pleth variability index(PVI)(during the surgery)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin Yang

attending physician

First Affiliated Hospital, Sun Yat-Sen University

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