Observational Study of Microvascular Circulation in Pediatric Heart Surgery
This study is looking at how blood flow in very small vessels (microcirculation) changes in children undergoing heart surgery for Tetralogy of Fallot. Doctors currently use tools like blood pressure to check overall blood flow, but this study explores if a handheld device called the Cytocam microcirculatory camera can give real-time information about these tiny vessels. The goal is to see how well the Cytocam works and to measure things like capillary density and microcirculatory flow during and after surgery. This study includes children from 1 day to 17 years old who have Tetralogy of Fallot, but excludes those with critical airway issues or certain genetic abnormalities of the mouth/tongue. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study with a planned enrollment of 40 participants. It is not specified if it is randomized or blinded.
- What's involved
- Measurements will be taken at several points: after intubation, during cardiopulmonary bypass (CPB) every hour, after CPB ends, and every 4 hours for the first 48 hours in the intensive care unit.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for the first 48 hours after being admitted to the intensive care unit.
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Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient
At a glance
Conditions
NCT07184476
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sitaram Emani · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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