Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient

Overview

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.

Primary outcome measures

• 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]
• 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]
• 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]
• 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]

Secondary outcome measures (2)

• 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United States · 1 center

• Boston Children's Hospital — Boston

Publications

• Mukaida H, Matsushita S, Kuwaki K, Inotani T, Minami Y, Saigusa A, Amano A. Time-dose response of oxygen delivery during cardiopulmonary bypass predicts acute kidney injury. J Thorac Cardiovasc Surg. 2019 Aug;158(2):492-499. doi: 10.1016/j.jtcvs.2018.10.148. Epub 2018 Nov 16. PMID 30578056
• Favia I, Garisto C, Rossi E, Picardo S, Ricci Z. Fluid management in pediatric intensive care. Contrib Nephrol. 2010;164:217-226. doi: 10.1159/000313733. Epub 2010 Apr 20. PMID 20428006
• Massey MJ, Larochelle E, Najarro G, Karmacharla A, Arnold R, Trzeciak S, Angus DC, Shapiro NI. The microcirculation image quality score: development and preliminary evaluation of a proposed approach to grading quality of image acquisition for bedside videomicroscopy. J Crit Care. 2013 Dec;28(6):913-7. doi: 10.1016/j.jcrc.2013.06.015. Epub 2013 Aug 21. PMID 23972316
• Erdem O, de Graaff JC, Hilty MP, Kraemer US, de Liefde II, van Rosmalen J, Ince C, Tibboel D, Kuiper JW. Microcirculatory Monitoring in Children with Congenital Heart Disease Before and After Cardiac Surgery. J Cardiovasc Transl Res. 2023 Dec;16(6):1333-1342. doi: 10.1007/s12265-023-10407-4. Epub 2023 Jul 14. PMID 37450208
• Mendelson AA, Lam F, Peirce SM, Murfee WL. Clinical perspectives on the microcirculation. Microcirculation. 2021 Apr;28(3):e12688. doi: 10.1111/micc.12688. No abstract available. PMID 33629399
• Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350. PMID 25647235
• Selewski DT, Cornell TT, Heung M, Troost JP, Ehrmann BJ, Lombel RM, Blatt NB, Luckritz K, Hieber S, Gajarski R, Kershaw DB, Shanley TP, Gipson DS. Validation of the KDIGO acute kidney injury criteria in a pediatric critical care population. Intensive Care Med. 2014 Oct;40(10):1481-8. doi: 10.1007/s00134-014-3391-8. Epub 2014 Jul 31. PMID 25079008
• Kuiper JW, Tibboel D, Ince C. The vulnerable microcirculation in the critically ill pediatric patient. Crit Care. 2016 Oct 30;20(1):352. doi: 10.1186/s13054-016-1496-x. PMID 27794361

Identifiers

NCT: NCT07184476 · IRB-P00050326

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗