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临床试验/NCT06776133
NCT06776133招募中不适用

Evaluation of the Correlation Between Vein Size Inferior Cava and Right Atrial Pressure in Pediatric Age and Creation of a Possible Predictive Model

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,100
试验地点
1
主要终点
Construction of a mathematical predictive model of RAP specifically for pediatric patients

研究概览

简要总结

The goal of this observational study is to demonstrate the presence of a correlation between echographic measurements of the inferior vena cava (IVC) normalized for the pediatric population and right atrial pressures (RAP) measured by central venous catheter (CVC) so as to create a predictive model of the value of right atrial pressures using echocardiographic parameters in the pediatric population. This study is single-center longitudinal and involves retrospective and prospective data collection.

详细描述

Primary objective:

  • To build a mathematical predictive model of RAP specifically for paediatric patients from echocardiographic parameters analysed on a retrospective cohort.

Secondary objectives:

  • To evaluate the accuracy on the paediatric patient of the mathematical model in use for the estimation of RAP in adult patients in a prospective cohort.
  • To test the mathematical model built in this study in a prospective cohort of patients OUTCOME With regard to the primary objective, a new patient-specific model will be built paediatric patient from different methods of ultrasound measurement of the IVC (maximum and minimum diameter expressed as z-score, ratio between the two diameters, ratio between maximum diameter and systolic diameter of the aorta).

systolic diameter of the aorta), as well as the patient's auxo-anthropometric values collected by means of the retrospective data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Pediatric patients aged 0-18 years undergoing central venous catheter (CVC) placement in the course of the diagnosis performed at our center
  • Obtaining informed consent from parent/guardian in case of minors

排除标准

  • Patients with univentricular cardiac physiology, nonsinus heart rhythm, mechanical ventilation, Inferior vena cava thrombosis and patients with isomerism

结局指标

主要结局

Construction of a mathematical predictive model of RAP specifically for pediatric patients

时间窗: Once

The following echocardiographic parameters related to inferior vena cava (IVC) measurements will be analyzed: maximum and minimum expressed as z-score, ratio of the two diameters, ratio of maximum diameter to the systolic systolic aorta. The patient's auxo-anthropometric values collected through the data will also be considered retrospective.

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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