Evaluating the link between vein size and heart pressure in children
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 Bologna · NCT06776133
This study is trying to see if measuring the size of a specific vein in children's hearts can help predict their heart pressure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06776133 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a correlation between echographic measurements of the inferior vena cava (IVC) and right atrial pressures (RAP) in pediatric patients. It involves both retrospective and prospective data collection at a single center, focusing on building a predictive model for RAP based on echocardiographic parameters. The study will analyze various ultrasound measurements of the IVC and patient-specific factors to create a tailored mathematical model for estimating RAP in children. Additionally, the accuracy of existing adult models will be evaluated in this pediatric cohort.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients aged 0-18 years who are undergoing central venous catheter placement for diagnostic purposes.
Not a fit: Patients with univentricular cardiac physiology, nonsinus heart rhythm, mechanical ventilation, inferior vena cava thrombosis, or isomerism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable predictive model for assessing heart pressure in pediatric patients, improving diagnosis and treatment.
How similar studies have performed: While this approach is focused on pediatric patients, similar studies in adults have shown success in using echocardiographic parameters to estimate heart pressures.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Simone Bonetti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Simone Bonetti, MD
- Email: simone.bonetti@aosp.bo.it
- Phone: 0512149024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, Acquired Heart Disease