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临床试验/NCT05283590
NCT05283590Unknown不适用

Automated Inferior Vena Cava Collapsibility Index for Assessing Fluid Responsiveness in Ventilated Patients After Cardiac Surgery.

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Fluid responsiveness rate 500cc of colloids over 10 min.

研究概览

简要总结

Echocardiographic measurement of inferior vena cava (IVC) collapsibility index (CI) with automated software analyses has been introduced. This study aims to assess the accuracy of IVC-CI (caval index) measurements as well as the ability to track fluid responsiveness (FRes) over time comparing the automated echocardiographic method with the pulse pressure variation (PPV) technique and the manual echocardiographic method in cardiac surgery patients.

详细描述

It is expected to have insights about the concordance rate. The automated echocardiographic method of measuring CI method may or may not meet the criteria for interchangeability with the thermodilution technique or the manual echocardiographic method.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than18 years old.
  • Cardiac surgical patients including (coronary artery bypass graft surgery, valvular surgeries, and aortic dissection surgeries)
  • Need for decision to administer IV fluids (hypotension that require assessment and possible fluid boluses defined as a systolic blood pressure less than 90mmHg. Normotensive patients who require fluid therapy with any other manifestation of low perfusion including tachycardia, low urine output, increased core-peripheral temperature gradient, serial increase in serum lactate, and serial increase in base deficit, and normotensive). The endpoint of fluid resuscitation is return normal blood pressure

排除标准

  • Contraindication for fluid administration including acute pulmonary edema.
  • Moderate or more tricuspid valve lesion or pulmonary hypertension (more 50 mmHg) where high central venous pressure is expected
  • Patients on hemodialysis.
  • Patient on intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO)
  • Irregular cardiac rhythm: patients with atrial fibrillation or frequent ectopics are excluded.
  • Patients with chest open
  • Poor echocardiography window (The images will be stored and analyzed by senior physician within the ICU certified in echocardiography)

结局指标

主要结局

Fluid responsiveness rate 500cc of colloids over 10 min.

时间窗: 30 minutes

defined as increase in the stoke volume by 15% after infusion of 500cc of colloids

次要结局

  • MAP(30 minutes)
  • VTI(30 minutes)
  • HR(30 minutes)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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