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Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient

Boston Children's Hospital logo

Boston Children's Hospital

Status

Not yet enrolling

Conditions

Tetrology of Fallot

Study type

Observational

Funder types

Other

Identifiers

NCT07184476
IRB-P00050326

Details and patient eligibility

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. 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.

Enrollment

40 estimated patients

Sex

All

Ages

1 day to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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