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临床试验/NCT07206732
NCT07206732尚未招募不适用

Ultrasound-Guided Inferior Vena Cava Assessment Versus Central Venous Pressure Monitoring in Early and Post-Resuscitation Detection of Hypovolemia Among Shocked Patients in the Emergency Department

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Correlation Between IVC Collapsibility Index and Central Venous Pressure

研究概览

简要总结

This study aims to compare ultrasound-guided inferior vena cava (IVC) assessment with central venous pressure (CVP) monitoring for the detection of hypovolemia in shock patients in the emergency department. The primary objective is to evaluate the diagnostic accuracy and clinical utility of IVC collapsibility index compared to CVP values in both early and post-resuscitation phases. The study will prospectively enroll shock patients, collect demographic and clinical data, and analyze the correlation between IVC and CVP measurements to determine their role in guiding fluid resuscitation and hemodynamic management.

详细描述

Hypovolemia is a major contributor to morbidity and mortality among patients presenting with shock in the emergency department. Early recognition and accurate assessment of intravascular volume status are essential for effective resuscitation. Central venous pressure (CVP) monitoring has traditionally been used but is invasive and may not always accurately reflect volume status. Ultrasound-guided inferior vena cava (IVC) assessment offers a non-invasive alternative, with the IVC collapsibility index shown to correlate with volume responsiveness. This prospective observational study will enroll patients diagnosed with shock and compare IVC measurements with CVP values during both early presentation and post-resuscitation phases. The findings are expected to provide evidence on the diagnostic agreement between IVC ultrasound and CVP monitoring, potentially supporting the use of IVC ultrasound as a rapid, reliable, and less invasive tool for guiding fluid therapy in emergency settings.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1- Adult patients aged ≥18 years. 2.Both male and female patients will be included in the study.
  • Presentation to the Emergency Department with clinical evidence of shock, defined by: Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg).
  • Evidence of tissue hypoperfusion (e.g., altered mental status, cold extremities, or oliguria).
  • Elevated serum lactate (>2 mmol/L).
  • Shock attributed to hypovolemic, septic, or hemorrhagic etiologies.
  • Patients requiring fluid resuscitation and hemodynamic monitoring.

排除标准

  • 1 - Patients younger than 18 years.
  • Pregnancy. 3.Cardiogenic or obstructive shock (e.g., cardiac tamponade, massive pulmonary embolism, or tension pneumothorax).
  • 4.Known inferior vena cava (IVC) anomalies (e.g., congenital absence, thrombosis).
  • 5. Increased intra-abdominal pressure or severe ascites.
  • Morbid obesity (BMI ≥40 kg/m²) or any condition interfering with adequate IVC ultrasound visualization.
  • 7. Prior central venous catheterization performed before Emergency Department arrival.
  • 8. Congestive heart failure (CHF) with left ventricular ejection fraction (LVEF <40%) or pulmonary hypertension.
  • 9. Refusal of the patient or legal guardian to participate in the study.

结局指标

主要结局

Correlation Between IVC Collapsibility Index and Central Venous Pressure

时间窗: IVC assessment will be performed at presentation and 1 hour post-resuscitation, while CVP will be monitored continuously during the first 6 hours after ED admission.

The primary outcome is to assess the diagnostic agreement between ultrasound-guided inferior vena cava (IVC) collapsibility index and central venous pressure (CVP) values in detecting hypovolemia among shock patients in the emergency department. Measurements will be collected at two time points: during early presentation and after initial fluid resuscitation. The outcome will be evaluated by analyzing correlation coefficients, sensitivity, and specificity of IVC measurements compared with CVP

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ahmed Mohamed Abd Elgwad

Principal Investigator at Emergency Medicine department Assiut University

Assiut University

研究点 (1)

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