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临床试验/NCT03572894
NCT03572894已完成不适用

Comparison of PVI and RPVI During a Tidal Volume Challenge Under General Anesthesia: A Prospective Validation Pilot Study

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年7月25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
35
试验地点
1
主要终点
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI

研究概览

简要总结

Pleth Variability Index (PVI) is a non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). PVI is commonly used in anesthesiology and has been validated to predict fluid responsiveness and optimize fluid administration in the surgical setting. However, the signal/noise ratio of PVI makes acute changes in PVI somewhat difficult to interpret at the bedside. Subsequently, a new algorithm entitled RPVI (Rainbow Pleth Variability Index), has been developed in order to improve the signal/noise ratio of PVI and facilitate its clinical use by practitioners. The details of this new proprietary built-in algorithm are unknown and no data are available to date. Therefore, the main objective of the study was to compare RPVI and PVI during dynamic changes in venous return induced by a tidal volume (Vt) challenge during mechanical ventilation in anesthetized patients. The hypothesis was that the agreement between both dynamic indices would be good.

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

  • Age > 18
  • Low or intermediate risk surgery or noninvasive procedures in the supine position
  • General anaesthesia and volume-controlled mechanical ventilation.

排除标准

  • Non sinus heart rhythm
  • Left Ventricular Ejection Fraction < 50%
  • Documented right ventricle failure
  • Lack of patient consent
  • Pregnancy
  • Minor patient or under tutorship
  • Presence of spontaneous ventilatory movements (attested by a real respiratory rate higher than the set respiratory rate)
  • Report HR / RR <3.6 (HR: heart rate, RR: respiratory rate)
  • Open chest surgery
  • Laparoscopic surgery
  • Vital or lateral decubitus surgery

结局指标

主要结局

Evaluation of the diagnostic characteristics of RPVI in comparison to PVI

时间窗: 30 minutes

Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements

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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Comparison of PVI and RPVI | 临床试验