NCT07184476 · Boston Children's Hospital
Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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
Evaluate the effective use of handheld vital microscopy (HVM), i.e. the Cytocam incident dark-field (IDF) microvascular camera along with CCTools software (Braedius-Medical Huizen, The Netherlands) in the microvasculature for pediatric cardiac surgery patient.
Capillary density measurements
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
Evaluate perioperative microcirculatory changes with relationship to routine clinical interventions in pediatric cardiac surgery care: Perfused vessel density (PVD) mm squared x mm squared (both continuous and categorical: lowest quartile vs rest) assessed per CCTools software.
Microcirculatory flow index grading
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
Microcirculatory flow index (MFI) (both continuous - a qualitative score graded as having no flow, intermittent, sluggish, or continuous flow ranging from 0 (no flow) to 3 (normal flow) with \< 2.6 defined as disturbed perfusion quality - categorical).
Surrogates of tissue perfusion and acute kidney injury
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
Surrogate of tissue perfusion with low urine output (\<0.5ml/kg/hr \> 1 yr, \< 1 ml/kg/hr \< 1 yr). Chi-squared and Correlation analysis
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot
Exclusion criteria
- Critical airway, congenital genetic abnormality of the mouth/tongue
Where
- Boston, Massachusetts
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Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations