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NCT Number: NCT07184476

Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient

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.

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Key information

Conditions

Tetrology of Fallot Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Tetralogy of Fallot

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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

Secondary outcomes

  1. Early outcome measures of prolonged ventilator times

    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

    Are microcirculatory changes associated with early outcome measures in pediatric patients? Association between microcirculation assessment of Perfused vessel density (PVD) mm squared x mm squared (both continuous and categorical: lowest quartile vs rest) assessed per CCTools software and prolonged ventilator times as defined by >48 hours.

  2. Adverse outcomes

    Time frame: - after intubation in operation room - 10 minutes after cardiopulmonary bypass (CPB) initiated - after cross clamp placed - every hour on CPB - every 4 hours during the first 48 hour after admitted to the intensive care unit

    Are microcirculatory changes associated with adverse outcomes in pediatric patients? Association of microcirculation flow index <2.6 (no units - using the Massey grading system) with the semi-automatic software analysis (CCTools). Averaging the values of each time point to major adverse reaction of stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Boyle

CONTACT

[email protected]

6173557077

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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