Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient
ConditionTetrology of Fallot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot
Disqualifiers
Critical airway, congenital genetic abnormality of the mouth/tongue
Trial population
Patients will be identified by preoperative assessment at Boston Children's Hospital.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Primary Tetrology of Fallot repair
Group B: Primary ventricular septal defect repair (VSD)
Trial outcomes
Primary outcomes
1
Braedius Cytocam efficacy in the pediatric surgery patient
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.
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 unit2
Capillary density measurements
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.
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 unit3
Microcirculatory flow index grading
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).
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 unit4
Surrogates of tissue perfusion and acute kidney injury
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
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 unitSecondary outcomes
1
Early outcome measures of prolonged ventilator times
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.
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 unit2
Adverse outcomes
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
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 unitSponsors and contacts
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Source ClinicalTrials.gov