Aortic-Radial Blood Pressure Gradient in Young Children Undergoing Heart Surgery
Official title: Evaluation of Aortic-Radial Blood Pressure Gradient in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Run by Pontificia Universidad Catolica de Chile · NCT07857811 · Data updated 2026-11-12
This study tests whether arm blood pressure readings match heart-level readings in children under 3 after heart surgery with a bypass machine, to see if arm readings are reliable enough to guide care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 3 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 2 sites (Santiago, Santiago Metropolitan and 1 other locations) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | April 20, 2026 |
| Study ends | April 21, 2028 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07857811 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 0 to 3 years with planned CPB-assisted cardiac surgery who have invasive radial arterial monitoring in place.
✕Probably not a fit
Patients without radial cannulation or with conditions precluding reliable radial arterial measurement may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study in pediatric patients under 3 years old undergoing cardiac surgery with cardiopulmonary bypass. It compares radial arterial pressure measured via a catheter to central aortic pressure obtained through the CPB circuit, focusing on the incidence and factors associated with a significant gradient. The study will collect biometric and surgical data, and examine how gradients relate to outcomes such as vasoactive drug use, transfusions, and ventilation duration. Analyses will include descriptive statistics, bivariate tests, and multivariate LASSO logistic regression to identify risk profiles. The aim is to inform arterial monitoring choices and perioperative hemodynamic management after bypass.
Why it matters
Potential benefit: If successful, the findings could improve accuracy of blood pressure monitoring and guide safer post-CPB management in young children.
How similar studies have gone: In adults, radial-to-central pressure gradients have been observed, but data in children under 3 are limited and this study addresses a knowledge gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients from 0 to 3 years old * Cardiac surgery with cardiopulmonary bypass (CPB) * Invasive blood pressure monitoring via radial artery Exclusion Criteria: * Patients in whom radial cannulation is not achieved * Significant vascular malformations that may interfere with or contraindicate invasive radial blood pressure measurement * Emergency surgeries * Reinterventions during the same hospital stay * Technical complications preventing reliable direct aortic pressure measurement
Where it's running
-
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, Chile Recruiting -
Red de Salud UC Christus
Santiago, Santiago Metropolitan, Chile Recruiting
Study contacts
- Principal investigator: Santiago Arze, MD — División de Anestesiología, Pontificia Universidad Católica de Chile
- Study coordinator: Santiago Arze, MD
- Email: sarze@uc.cl
- Phone: +56955049217
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.