Tetrology of Fallot
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Boston Children's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Braedius Cytocam efficacy in the pediatric surgery patient | - 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 | - 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 | - 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 | - 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
| Measure | Time frame | Description |
|---|---|---|
| Early outcome measures of prolonged ventilator times | - 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. |
| Adverse outcomes | - 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 |
Countries
United States
Contacts
CONTACTSharon Boyle
PRINCIPAL_INVESTIGATORSitaram Emani
Boston Children's Hospital
Outcome results
None listed