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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-3
SponsorPontificia Universidad Catolica de Chile

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients from 0 to 3 years old

Cardiac surgery with cardiopulmonary bypass (CPB)

Invasive blood pressure monitoring via radial artery

Disqualifiers

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

Trial population

Pediatric patients from 0-3 years of age

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Placement of a pressure transducer at the accessory port of the CPB arterial cannula

    Other intervention

    Placement of a pressure transducer at the accessory port of the cardiopulmonary bypass (CPB) arterial cannula during the final phase of CPB and the immediate post-CPB period.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Study group1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the occurrence of a significant radial-to-aortic (R-Ao) pressure gradient during the immediate post-cardiopulmonary bypass (CPB) period

A significant radial-to-aortic (R-Ao) pressure gradient is defined as a \>20% difference in SBP or \>10% difference in MAP sustained for \>5 minutes) during the immediate post-cardiopulmonary bypass (CPB) period

Time frame
within 15 minutes from the weaning of the CBP

Secondary outcomes

1

To determine the incidence of the R-Ao gradient in pediatric patients undergoing cardiac surgery with CPB and compare it with reported rates in the adult literature.

R-Ao Gradient Incidence: percentage of positive finding to the total of recruited patients in the study. Reported Rates in adult population: As per an exhaustive review of previous literature.

Time frame
Within the first 15 minutes after CPB weaning.
2

To identify risk factors associated with a higher R-Ao gradient, based on patient biometric parameters and surgical variables

Patient variables: age, body surface area \[BSA\], radial artery diameter Surgery variables: CPB duration and use of hypothermia Outcome Measure: Odds Ratio

Time frame
From enrollment to 48 hours after surgery
3

To compare vasoactive drug requirements/dosages between patients with and without a significant arterial gradient

The comparison will be made using VIS score, as: VIS = dopamine + dobutamine + (100 × epinephrine) + (100 × norepinephrine) + (10 × milrinone) + (10,000 × vasopressin) It will be measured at three time periods: 30 mins post CPB, Postoperative Day 1 and Postoperative Day 2

Time frame
within 30 minutes from the weaning of the CBP, up to 48 hours after surgery.
4

To compare the duration of invasive mechanical ventilation between patients with and without a significant arterial gradient.

Time frame
within the first 48 hours following weaning of the CBP

Other outcomes

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