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NCT Number: NCT06776133

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Simone Bonetti, MD

CONTACT

[email protected]

0512149024

About this study

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.

With regard to secondary objectives, the mathematical model in use for the patient will be applied adult patient to estimate the RAP in our patients and the value obtained will be compared with the value measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simone Bonetti, MD

CONTACT

[email protected]

0512149024

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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