A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- 否
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.)