Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient

Conditions

• Tetrology of Fallot

Eligibility Criteria

Sex

ALL

Age

1 Day - 17 Years

Healthy Volunteers

Not accepted

Study Details

The pediatric cardiac surgery patient endures a tremendous number of physiologic alterations during surgery and cardiopulmonary bypass (CPB) that lasts well into the recovery period. Most of the hemodynamic data are assessed and treated with macrovascular assessment tools such as blood pressure and central venous line measures. Studies show there may be an incoherence of macrovascular to microvascular assessment; i.e. a patient with a stable macrovascular status may not be in the state of microvascular stability. The use of a handheld device called Cytocam incident dark-field (IDF) microcirculatory camera (Braedius Medical, Huizen, Netherlands) gives real-time video screening and data feedback to assess the microvasculature in the hemodynamically labile patient.

Key Dates

Start date

Mar 18, 2026

Status verified

Apr 2026

Primary completion

Mar 17, 2027

Completion

Mar 17, 2027

Study Design

Enrollment

40 participants (estimated)

Arms

• Arm: Primary Tetrology of Fallot repair
  Cyanotic physiology with Tetrology of Fallot w/pulmonary stenosis or atresia
• Arm: Primary ventricular septal defect repair (VSD)
  Acyanotic lesion with VSD repair patch graft

Primary Outcome Measure

Braedius Cytocam efficacy in the pediatric surgery patient [ Time Frame: - After intubation in operation room - 10 minutes after cardiopulmonary bypass (CPB) initiated - after cross clamp placed - every hour on CPB - after CPB ends - every 4 hours during the first 48 hours after admitted to the intensive care unit ]

Central Contacts

• Sharon Boyle
  6173557077
  [email protected]

Locations (1)

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