Tetrology of FallotNCT07184476
Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient
An observational study of Tetrology of Fallot, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Tetrology of Fallot
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 17 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients will be identified by preoperative assessment at Boston Children's Hospital.
Who may be able to join
- All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot
Who cannot join
- Critical airway, congenital genetic abnormality of the mouth/tongue
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Sharon Boyle, 6173557077, sharon.boyle@cardio.chboston.org
sharon.boyle@cardio.chboston.org
About this study
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
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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.
Measured: - 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).
Measured: - 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
Measured: - 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
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.
Measured: - 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
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
Measured: - 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start18 Mar 2026
- Primary completion17 Mar 2027 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Tetrology of FallotStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sitaram Emani, Boston Children's Hospital
- Investigators
- Sitaram Emani, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184476
- Sponsor's protocol ID
- IRB-P00050326
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2025
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Determining efficacy of using the device in Boston Childrens Hospital
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.
PubMed 30578056Favia 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.
PubMed 20428006Massey 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.
PubMed 23972316Erdem 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.
PubMed 37450208Mendelson 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.
PubMed 33629399Pediatric 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.
PubMed 25647235Selewski 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.
PubMed 25079008Kuiper 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.
PubMed 27794361Top 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.
PubMed 21297516Watchorn 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.
PubMed 31764623Gilbert-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.
PubMed 26797680Alten 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.
PubMed 28737598Scolletta 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.
PubMed 27440632Buijs 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.
PubMed 24200889Akin 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.
PubMed 29073930
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient
- ClinicalTrials.gov ID
- NCT07184476
- Acronym / sponsor ID
- IRB-P00050326
- Conditions
- Tetrology of Fallot
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 17 Mar 2027 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients will be identified by preoperative assessment at Boston Children's Hospital.
Key inclusion criteria (1 listed)
- All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot
Key exclusion criteria (1 listed)
- Critical airway, congenital genetic abnormality of the mouth/tongue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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 (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
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
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 30578056Mukaida 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.
- Background: PubMed 20428006Favia 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.
- Background: PubMed 23972316Massey 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.
- Background: PubMed 37450208Erdem 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.
- Background: PubMed 33629399Mendelson 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.
- Background: PubMed 25647235Pediatric 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.
- Background: PubMed 25079008Selewski 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.
- Background: PubMed 27794361Kuiper 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.
- Background: PubMed 21297516Top 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.
- Background: PubMed 31764623Watchorn 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.
- Background: PubMed 26797680Gilbert-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.
- Background: PubMed 28737598Alten 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.
- Braedius Medical Cytocam Microcirculation camera websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Determining efficacy of using the device in Boston Childrens Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sitaram Emani principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetrology of Fallot, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Boyle (6173557077, sharon.boyle@cardio.chboston.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07184476, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.