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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Placement of a pressure transducer at the accessory port of the CPB arterial cannula
Other interventionPlacement 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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
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
To compare the duration of invasive mechanical ventilation between patients with and without a significant arterial gradient.
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