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临床试验/NCT06143111
NCT06143111
尚未招募
不适用

A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 100 人2023年11月20日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Stroke Volume Variation
发起方
RenJi Hospital
入组人数
100
试验地点
1
主要终点
The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ
状态
尚未招募
最后更新
2年前

概览

简要总结

Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.

注册库
clinicaltrials.gov
开始日期
2023年11月20日
结束日期
2025年12月31日
最后更新
2年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Age 18≤ Age ≤
  • patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
  • 18 kg/m2≤BMI≤30 kg/m2
  • ASA classification I-III
  • Patients signed informed consent form

排除标准

  • Arrhythmias
  • The patient is diagnosed with severe cardiovascular disease(pulmonary arterial hypertension、left ventricular ejection fraction\< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy)
  • Severe heart failure (METS\<4)
  • The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
  • The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
  • There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed
  • History of allergy to anesthetic drugs
  • Weight\<40kg
  • Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland

结局指标

主要结局

The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ

时间窗: From anesthesia induction to the nonresponsive VLS about one hour.

After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the agreement of the two SVVs.

次要结局

  • The capacity to predict fluid responsiveness.(From anesthesia induction to the nonresponsive VLS about one hour.)

研究点 (1)

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