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Evaluation of Aortic-Radial Blood Pressure Gradient in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Evaluation of Aortic-Radial Blood Pressure Gradient in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Recruiting
3 years and younger
All
Phase N/A

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Overview

Invasive blood pressure monitoring is essential during heart surgery. Usually, doctors measure blood pressure using a small tube (a catheter) placed in an artery, typically in the wrist or arm. During surgeries that require a heart-lung machine (cardiopulmonary bypass), doctors can also measure blood pressure directly near the heart in the main artery (the aorta). This is done using a tube already in place for the machine, so no extra procedure is needed.

In adult patients, doctors have noticed that blood pressure readings taken at the arm can sometimes be significantly different from readings taken near the heart right after coming off the heart-lung machine. This difference could lead to unnecessary or incorrect treatments if medical teams rely only on arm readings. However, it is still unknown whether this same difference occurs in children.

The goal of this study is to measure and compare blood pressure from both the arm and near the heart in children aged 3 years and younger as they come off the heart-lung machine during heart surgery. This research will help medical teams make safer, more accurate treatment decisions for children undergoing heart surgery.

Description

Accurate arterial blood pressure monitoring is essential during and after cardiopulmonary bypass (CPB) in pediatric cardiac surgery. However, a significant gradient between radial and central aortic pressure has been reported, which could lead to erroneous clinical decisions if radial pressure is overestimated. Although this phenomenon has been studied in adults, its incidence, associated factors, and clinical implications in pediatric patients under 3 years of age remain to be clearly established.

This study proposes a prospective observational cohort design including 100 patients under 3 years of age undergoing cardiac surgery with CPB and invasive radial arterial monitoring. The study will evaluate the incidence of a significant radial-to-aortic gradient (defined as a \>20% difference in SBP or \>10% in MAP sustained for more than 5 minutes), alongside biometric and surgical risk factors, and its relationship with clinical outcomes such as vasoactive drug requirements, blood transfusions, and duration of mechanical ventilation.

Statistical analysis will be performed using descriptive statistics, bivariate testing, and multivariate LASSO logistic regression. This study is expected to identify a pediatric risk profile for developing a significant pressure gradient, thereby optimizing decision-making regarding arterial monitoring sites and post-CPB hemodynamic management. Ultimately, this research aims to address a clinically relevant knowledge gap and enhance perioperative safety in this highly vulnerable population.

Eligibility

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

Study details
    Gradient Between Radial and Central Aortic Pressure After Cardiopulmonary Bypass

NCT07857811

Pontificia Universidad Catolica de Chile

21 October 2026

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