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

NCT06776133 | Recruiting

• 1 other identifier: PED-RAP-IVC
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease; Acquired Heart Disease

Outcome Measures

Primary Outcomes (1)

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

  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.

  Once

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective population consists of all patients admitted at the Pediatric Cardiology Unit of IRCCS AOU of Bologna and underwent central venous catheter placement (CVC) during the normal diagnostic-therapeutic course from 1st January of 2012 for which a complete echocardiography was performed within 1 hour of RAP (right atrial pressure) measurement. The prospective population consists of all patients admitted at the Pediatric Cardiology Unit of the IRCCS AOU of Bologna from the time of approval by the ethics committee and undergoing central venous catheter placement for 12 months after the start of this study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Simone Bonetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Bonetti, MD

CONTACT

0512149024; simone.bonetti@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 15, 2025
• Study Start: August 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-11

Locations

IT (1)