Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient

NCT07184476 | Not Yet Recruiting

• 1 other identifier: IRB-P00050326
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tetrology of Fallot

Outcome Measures

Primary Outcomes (4)

• 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.

  - 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

  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.

  - 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

  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).

  - 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

  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

  - 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Primary Tetrology of Fallot repair

Cyanotic physiology with Tetrology of Fallot w/pulmonary stenosis or atresia

Primary ventricular septal defect repair (VSD)

Acyanotic lesion with VSD repair patch graft

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified by preoperative assessment at Boston Children's Hospital.

You may qualify if:

• All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot

You may not qualify if:

• Critical airway, congenital genetic abnormality of the mouth/tongue

Sponsors & Collaborators

• Boston Children's Hospital: lead

Related Publications (19)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Top AP, Ince C, Schouwenberg PH, Tibboel D. Inhaled nitric oxide improves systemic microcirculation in infants with hypoxemic respiratory failure. Pediatr Crit Care Med. 2011 Nov;12(6):e271-4. doi: 10.1097/PCC.0b013e31820ac0b3.

  PMID: 21297516 BACKGROUND

• Watchorn JC, Fargaly H, Gilani M, Assadi J, Deitchman AR, Naumann DN, Wollborn J, Goebel U, McCurdy MT, Hutchings SD. The Reproducibility of the Point of Care Microcirculation (POEM) Score When Used to Assess Critically Ill Patients: A Multicenter Prospective Observational Study. Shock. 2020 Jul;54(1):15-20. doi: 10.1097/SHK.0000000000001474.

  PMID: 31764623 BACKGROUND

• Gilbert-Kawai E, Coppel J, Bountziouka V, Ince C, Martin D; Caudwell Xtreme Everest and Xtreme Everest 2 Research Groups. A comparison of the quality of image acquisition between the incident dark field and sidestream dark field video-microscopes. BMC Med Imaging. 2016 Jan 21;16:10. doi: 10.1186/s12880-015-0078-8.

  PMID: 26797680 BACKGROUND

• Alten JA, Klugman D, Raymond TT, Cooper DS, Donohue JE, Zhang W, Pasquali SK, Gaies MG. Epidemiology and Outcomes of Cardiac Arrest in Pediatric Cardiac ICUs. Pediatr Crit Care Med. 2017 Oct;18(10):935-943. doi: 10.1097/PCC.0000000000001273.

  PMID: 28737598 BACKGROUND

• Scolletta S, Marianello D, Isgro G, Dapoto A, Terranova V, Franchi F, Baryshnikova E, Carlucci C, Ranucci M. Microcirculatory changes in children undergoing cardiac surgery: a prospective observational study. Br J Anaesth. 2016 Aug;117(2):206-13. doi: 10.1093/bja/aew187.

  PMID: 27440632 BACKGROUND

• Buijs EA, Verboom EM, Top AP, Andrinopoulou ER, Buysse CM, Ince C, Tibboel D. Early microcirculatory impairment during therapeutic hypothermia is associated with poor outcome in post-cardiac arrest children: a prospective observational cohort study. Resuscitation. 2014 Mar;85(3):397-404. doi: 10.1016/j.resuscitation.2013.10.024. Epub 2013 Nov 5.

  PMID: 24200889 BACKGROUND

• Akin S, Dos Reis Miranda D, Caliskan K, Soliman OI, Guven G, Struijs A, van Thiel RJ, Jewbali LS, Lima A, Gommers D, Zijlstra F, Ince C. Functional evaluation of sublingual microcirculation indicates successful weaning from VA-ECMO in cardiogenic shock. Crit Care. 2017 Oct 26;21(1):265. doi: 10.1186/s13054-017-1855-2.

  PMID: 29073930 BACKGROUND

• Aksu U, Yavuz-Aksu B, Goswami N. Microcirculation: Current Perspective in Diagnostics, Imaging, and Clinical Applications. J Clin Med. 2024 Nov 10;13(22):6762. doi: 10.3390/jcm13226762.

  PMID: 39597906 BACKGROUND

• Hilty MP, Guerci P, Ince Y, Toraman F, Ince C. MicroTools enables automated quantification of capillary density and red blood cell velocity in handheld vital microscopy. Commun Biol. 2019 Jun 19;2:217. doi: 10.1038/s42003-019-0473-8. eCollection 2019.

  PMID: 31240255 BACKGROUND

• Ince C, Boerma EC, Cecconi M, De Backer D, Shapiro NI, Duranteau J, Pinsky MR, Artigas A, Teboul JL, Reiss IKM, Aldecoa C, Hutchings SD, Donati A, Maggiorini M, Taccone FS, Hernandez G, Payen D, Tibboel D, Martin DS, Zarbock A, Monnet X, Dubin A, Bakker J, Vincent JL, Scheeren TWL; Cardiovascular Dynamics Section of the ESICM. Second consensus on the assessment of sublingual microcirculation in critically ill patients: results from a task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2018 Mar;44(3):281-299. doi: 10.1007/s00134-018-5070-7. Epub 2018 Feb 6.

  PMID: 29411044 BACKGROUND

• Dilken O, Ergin B, Ince C. Assessment of sublingual microcirculation in critically ill patients: consensus and debate. Ann Transl Med. 2020 Jun;8(12):793. doi: 10.21037/atm.2020.03.222.

  PMID: 32647718 BACKGROUND

Related Links

• Braedius Medical Cytocam Microcirculation camera website

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery, Harvard Medical School

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 19, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09