Congenital Heart DiseaseNCT07361523
Using Near-Infrared Spectroscopy Devices to Assess Myocardial and Visceral Perfusion During Complex Congenital Cardiac Surgery
An observational study of Congenital Heart Disease, run by Boston Children's Hospital.
Trial summary
The use of near infrared spectroscopy (NIRS) is a technique that has recently been incorporated by several other surgical specialties to measure tissue perfusion, such as in plastic surgery to allow for earlier detection of free flap vascular compromise in the postoperative monitoring protocol, with promising… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Tissue oximeter (IntraOx)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2027
- How long will I take part?
- 1 Day
- 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 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital identified by the PI and the study coordinator to have concern for decreased myocardial and peripheral perfusion for any reason. This may include, but will not be limited to, patients with history of myocardial ischemia, surgical procedures on the coronary arteries or operating near the coronary arteries that may impact myocardial perfusion, surgical procedures that may impact systemic perfusion, patients with history of coronary artery disease, patients with history of angina, patients with history of rheumatic disease that may impact perfusion, and patients with previous history of poor ventricular function, arrhythmia, or other complications following cardiopulmonary bypass.
Who may be able to join
- Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital are all eligible for participation in this study.
- All subjects undergoing congenital heart surgery at Boston Children's Hospital will be screened for inclusion in this study. Screening will prioritize identifying patients with concern for decreased myocardial and peripheral perfusion for any reason, as designated by Dr. Sitaram Emani's clinical judgement.
- Eligibility will be reviewed in advance by screening upcoming surgical procedures. All patients over 1 year of age will be eligible for participation in this study and screened for inclusion. Any patient at risk for malperfusion during bypass (e.g. Fontans, biventricular repair, long cross-clamp times, etc.) will be identified ahead of time and prioritized for inclusion in the study.
Who cannot join
- Any records flagged for "research opt out."
- Neonates and children undergoing surgery less than 1 year of age
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The use of near infrared spectroscopy (NIRS) is a technique that has recently been incorporated by several other surgical specialties to measure tissue perfusion, such as in plastic surgery to allow for earlier detection of free flap vascular compromise in the postoperative monitoring protocol, with promising outcomes. IntraOx is a handheld oximeter that uses NIRS to measure tissue oxygen saturation and that has been used as an alternative to indocyanine green (ICG) to assess bowel perfusion in colorectal anastomotic cases. IntraOx is a promising technology that is also sterile and easy to use that can be incorporated into congenital heart surgery procedures to evaluate myocardial perfusion in a time sensitive manner. This technology could also be used on the liver to assess systemic perfusion as another indicator of cardiac function, in conjunction with the intraoperative transesophageal echocardiography (TEE). This could provide more concrete data about not only myocardial perfusion, but systemic perfusion as well. This data could be critical to help surgeons make surgical decisions and may help to improve patient outcomes.
This will be a prospective review of the use of the Intra.Ox device during cardiac surgery at different timepoints during the procedure to assess perfusion. This device is FDA-approved for use in adults but not approved for use in children and will be investigational in children.
The primary objective of this study is to test whether the Intra.Ox (Vioptix Inc.) using near-infrared spectroscopy to measure tissue oxygen saturation can be used to evaluate myocardial and visceral perfusion at different time points during complex congenital heart surgery, and particularly those involving coronary artery manipulation such as patients undergoing arterial switch operations or stage 1 palliation for hypoplastic left heart syndrome. The investigators would also use this device on the liver to assess systemic perfusion. The secondary objective is to evaluate whether the investigators would be able to use the information from the Intra.Ox device to make clinical decisions that can improve patient outcomes.
- Conditions
- Congenital Heart Disease
- Being tested
- Tissue oximeter (IntraOx)
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue oximeter (IntraOx)Device
The Intra.Ox device will be used to measure %StO2 readings taken at different time points during the surgery, including: (1) prior to bypass when the heart is being perfused by the coronary arteries, (2) after the patient is placed on cardiopulmonary bypass (CPB) but prior to placing a cross-clamp, (3) after placing a cross-clamp when the heart is not being perfused by CPB, and (4) after the patient is taken off CPB and the heart is re-perfusing. These readings will not impact the surgical management of the patient, and the congenital heart surgery will be carried out per standard of care according to the judgement of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| IntraOx Device Patients | Pediatric patients undergoing congenital heart surgery with risk for myocardial or peripheral ischemia with use of IntraOx device intraoperatively to assess myocardial and visceral perfusion at 4 different time points Receives: Device: Tissue oximeter (IntraOx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
Oxygen saturation levels measured from: pulse oximetry, tissue oximeter, arterial blood gases, and venous blood gases in units of %
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: ALP
Post-operative liver function tests: Alkaline Phosphatase (ALP) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Liver Function Test: AST
Post-operative liver function test: AST (Aspartate Aminotransferase) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Liver function Test: ALT
Post-operative liver function test: ALT (Alanine Transaminase) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Cardiac function
Measuring cardiac function as measured by ejection fraction (in %) in post-operative echocardiogram results.
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Kidney function
Laboratory values of BUN and Creatinine (Cr) in units of mg/dL as a measurement of kidney function and perfusion
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Mortality and major complications
Major complications as defined by the STS and Congenital Heart Surgeons Society including renal failure requiring dialysis, permanent neurologic deficit, pacemaker, paralyzed diaphragm, mechanical circulatory support, and unplanned reintervention. This will be recorded as one outcome (whether or not a patient had mortality and major complications) and not measuring multiple multiple assessments; it is a quantitative assessment of whether or not a patient encountered one of the major complications or mortality as defined above. There are no units of measure.
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Lactate
Lactate levels in mmol/L as measurement for tissue perfusion.
Measured: Day 0 ("baseline") up to 2 weeks post-operation
pH
pH from arterial blood gas and venous blood gas to measure blood acidity/alkalinity.
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Blood gas: PaO2
PaO2 (partial pressures of oxygen) in mmHg from arterial and venous blood gas blood tests
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Blood Gas: PaCO2
PaCO2 (partial pressures of carbon dioxide) in mmHg from arterial and venous blood gas blood tests
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Bicarbonate
Bicarbonate values from arterial and venous blood gas in units of mmol/L. This is one outcome measure that will be recorded, not multiple assessments with different units of measure. Bicarbonate values will be recorded from two different blood gas sources in mmol/L.
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Echocardiography qualitative descriptions
Measurement and recording of qualitative written report from cardiologist interpretation of echocardiography, specifically assessing for reports of 1) valvular dysfunction (regurgitation or stenosis), 2) myocardial dysfunction, hypokinesis, filling defects, etc. or 3) any other abnormalities written in qualitative report relating to cardiac function
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Lactate
Lactate levels in mmol/L as measurement for tissue perfusion
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Secondary outcomes (19)
Intensive care unit length of stay
Intensive care unit length of stay in days
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Hospital length of stay
Hospital length of stay of stay in days
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Liver function tests: bilirubin
Measurements of bilirubin in units of mg/dL to assess liver function as indicator of tissue perfusion
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: protein
Total protein in g/dL as measure of liver function
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: albumin
Albumin in g/dL as measure of liver function
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: sodium
Basic metabolic panel laboratory value measuring sodium in units of mEq/L
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: potassium
Basic metabolic panel laboratory values measuring potassium in units of mEq/L
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: chloride
Basic metabolic panel laboratory values measuring chloride in units of mEq/L
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: CO2
Basic metabolic panel laboratory values measuring CO2 in units of mEq/L
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Basic metabolic panel: glucose
Basic metabolic panel glucose levels in units of mg/dL
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Basic metabolic panel: calcium
Basic metabolic panel calcium levels in units of mg/dL
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Aortic valve diameter
Aortic heart valve annulus diameters measured in mm
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Mitral valve diameter
Mitral valve annulus diameters measured in mm
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Pulmonary valve diameter
Pulmonary valve annulus diameters measured in mm
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Tricuspid valve diameter
Tricuspid valve annulus diameters measured in mm
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: aortic valve
Pressure gradients across aortic valve measured on echocardiography measured in mmHg
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: mitral valve
Pressure gradients across mitral valve measured on echocardiography measured in mmHg
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: tricuspid valve
Pressure gradients across tricuspid valve measured on echocardiography measured in mmHg
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: pulmonic valve
Pressure gradients across pulmonic valve measured on echocardiography measured in mmHg
Measured: Day 0 ("baseline") up to 2 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ViOptix Canada
- Responsible party
- Principal investigator, Sitaram Emani, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361523
- Sponsor's protocol ID
- IRB-P00052229
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pasquali SK, Shahian DM, O'Brien SM, Jacobs ML, Gaynor JW, Romano JC, Gaies MG, Hill KD, Mayer JE, Jacobs JP. Development of a Congenital Heart Surgery Composite Quality Metric: Part 1-Conceptual Framework. Ann Thorac Surg. 2019 Feb;107(2):583-589. doi: 10.1016/j.athoracsur.2018.07.037. Epub 2018 Sep 15.
PubMed 30227127Jacobs JP, Jacobs ML, Austin EH 3rd, Mavroudis C, Pasquali SK, Lacour-Gayet FG, Tchervenkov CI, Walters H 3rd, Bacha EA, Nido PJ, Fraser CD, Gaynor JW, Hirsch JC, Morales DL, Pourmoghadam KK, Tweddell JS, Prager RL, Mayer JE. Quality measures for congenital and pediatric cardiac surgery. World J Pediatr Congenit Heart Surg. 2012 Jan 1;3(1):32-47. doi: 10.1177/2150135111426732.
PubMed 23804682Koolen PGL, Vargas CR, Ho OA, Ibrahim AMS, Ricci JA, Tobias AM, Winters HAH, Lin SJ, Lee BT. Does Increased Experience with Tissue Oximetry Monitoring in Microsurgical Breast Reconstruction Lead to Decreased Flap Loss? The Learning Effect. Plast Reconstr Surg. 2016 Apr;137(4):1093-1101. doi: 10.1097/01.prs.0000481071.59025.82.
PubMed 27018663Oskarsson G, Pesonen E, Munkhammar P, Sandstrom S, Jogi P. Normal coronary flow reserve after arterial switch operation for transposition of the great arteries: an intracoronary Doppler guidewire study. Circulation. 2002 Sep 24;106(13):1696-702. doi: 10.1161/01.cir.0000030937.27602.bd.
PubMed 12270865Yates RW, Marsden PK, Badawi RD, Cronin BF, Anderson DR, Tynan MJ, Maisey MN, Baker EJ. Evaluation of myocardial perfusion using positron emission tomography in infants following a neonatal arterial switch operation. Pediatr Cardiol. 2000 Mar-Apr;21(2):111-8. doi: 10.1007/s002469910015.
PubMed 10754077Noel CV, Krishnamurthy R, Masand P, Moffett B, Schlingmann T, Cheong BY, Krishnamurthy R. Myocardial Stress Perfusion MRI: Experience in Pediatric and Young-Adult Patients Following Arterial Switch Operation Utilizing Regadenoson. Pediatr Cardiol. 2018 Aug;39(6):1249-1257. doi: 10.1007/s00246-018-1890-z. Epub 2018 May 10.
PubMed 29748700Sherwinter D, Chandler P, Martz J. The use of tissue oxygen measurements compared to indocyanine green imaging for the assessment of intraoperative tissue viability of human bowel. Surg Endosc. 2022 Mar;36(3):2192-2196. doi: 10.1007/s00464-021-08737-y. Epub 2021 Sep 22.
PubMed 34550436Khavanin N, Darrach H, Kraenzlin F, Yesantharao PS, Sacks JM. The Intra.Ox Near-Infrared Spectrometer Measures Variations in Flap Oxygenation That Correlate to Flap Necrosis in a Preclinical Rodent Model. Plast Reconstr Surg. 2021 May 1;147(5):1097-1104. doi: 10.1097/PRS.0000000000007894.
PubMed 33835088Gonzalez-Jacobo A, Chandler P, Martz J, Sherwinter D. Tissue Oximetry as a Potential Alternative to Indocyanine Green (ICG) Perfusion Assessment in Colorectal Anastomotic Cases. Surg Laparosc Endosc Percutan Tech. 2023 Apr 1;33(2):207-210. doi: 10.1097/SLE.0000000000001161.
PubMed 36971520Khavanin N, Almaazmi H, Darrach H, Kraenzlin F, Safar B, Sacks JM. Comparison of the ViOptix Intra.Ox Near Infrared Tissue Spectrometer and Indocyanine Green Angiography in a Porcine Bowel Model. J Reconstr Microsurg. 2020 Jul;36(6):426-431. doi: 10.1055/s-0040-1702163. Epub 2020 Feb 23.
PubMed 32088921Nguyen MB, Zhang N, Baranger J, Aguet J, Friedberg MK, Barron DJ, Honjo O, Mertens LL, Villemain O. Ultrafast Power Doppler for Detecting Intraoperative Myocardial Perfusion in Infants With Critical Congenital Heart Disease. JACC Adv. 2023 Apr 12;2(3):100290. doi: 10.1016/j.jacadv.2023.100290. eCollection 2023 May. No abstract available.
PubMed 38939593Said SM, Marey G, Hiremath G. Intraoperative fluorescence with indocyanine green in congenital cardiac surgery: Potential applications of a novel technology. JTCVS Tech. 2021 Feb 25;8:144-155. doi: 10.1016/j.xjtc.2021.02.026. eCollection 2021 Aug.
PubMed 34401838Goldman ME, Mindich BP. Intraoperative cardioplegic contrast echocardiography for assessing myocardial perfusion during open heart surgery. J Am Coll Cardiol. 1984 Nov;4(5):1029-34. doi: 10.1016/s0735-1097(84)80067-4.
PubMed 6333444Cyran SE, Kimball TR, Meyer RA, Bailey WW, Lowe E, Balisteri WF, Kaplan S. Efficacy of intraoperative transesophageal echocardiography in children with congenital heart disease. Am J Cardiol. 1989 Mar 1;63(9):594-8. doi: 10.1016/0002-9149(89)90905-3.
PubMed 2919563Nguyen MB, Zhang N, Mertens LL, Barron D, Honjo O, Venet M, Baranger J, Villemain O. Noninvasive assessment of myocardial perfusion using ultrafast ultrasound: clinical study for congenital heart disease. Eur Heart J Imaging Methods Pract. 2025 Jan 16;3(1):qyaf007. doi: 10.1093/ehjimp/qyaf007. eCollection 2025 Jan.
PubMed 39974276
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Near-Infrared Spectroscopy Devices to Assess Myocardial and Visceral Perfusion During Complex Congenital Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07361523
- Acronym / sponsor ID
- IRB-P00052229
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- ViOptix Canada
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (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 use of near infrared spectroscopy (NIRS) is a technique that has recently been incorporated by several other surgical specialties to measure tissue perfusion, such as in plastic surgery to allow for earlier detection of free flap vascular compromise in the postoperative monitoring protocol, with promising outcomes. IntraOx is a handheld oximeter that uses NIRS to measure tissue oxygen saturation and that has been used as an alternative to indocyanine green (ICG) to assess bowel perfusion in colorectal anastomotic cases. IntraOx is a promising technology that is also sterile and easy to use that can be incorporated into congenital heart surgery procedures to evaluate myocardial perfusion in a time sensitive manner. This technology could also be used on the liver to assess systemic perfusion as another indicator of cardiac function, in conjunction with the intraoperative transesophageal echocardiography (TEE). This could provide more concrete data about not only myocardial perfusion, but systemic perfusion as well. This data could be critical to help surgeons make surgical decisions and may help to improve patient outcomes.
This will be a prospective review of the use of the Intra.Ox device during cardiac surgery at different timepoints during the procedure to assess perfusion. This device is FDA-approved for use in adults but not approved for use in children and will be investigational in children.
The primary objective of this study is to test whether the Intra.Ox (Vioptix Inc.) using near-infrared spectroscopy to measure tissue oxygen saturation can be used to evaluate myocardial and visceral perfusion at different time points during complex congenital heart surgery, and particularly those involving coronary artery manipulation such as patients undergoing arterial switch operations or stage 1 palliation for hypoplastic left heart syndrome. The investigators would also use this device on the liver to assess systemic perfusion. The secondary objective is to evaluate whether the investigators would be able to use the information from the Intra.Ox device to make clinical decisions that can improve patient outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IntraOx Device Patients | – | Device: Tissue oximeter (IntraOx)Pediatric patients undergoing congenital heart surgery with risk for myocardial or peripheral ischemia with use of IntraOx device intraoperatively to assess myocardial and visceral perfusion at 4 different time points |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital identified by the PI and the study coordinator to have concern for decreased myocardial and peripheral perfusion for any reason. This may include, but will not be limited to, patients with history of myocardial ischemia, surgical procedures on the coronary arteries or operating near the coronary arteries that may impact myocardial perfusion, surgical procedures that may impact systemic perfusion, patients with history of coronary artery disease, patients with history of angina, patients with history of rheumatic disease that may impact perfusion, and patients with previous history of poor ventricular function, arrhythmia, or other complications following cardiopulmonary bypass.
Key inclusion criteria (3 listed)
- Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital are all eligible for participation in this study.
- All subjects undergoing congenital heart surgery at Boston Children's Hospital will be screened for inclusion in this study. Screening will prioritize identifying patients with concern for decreased myocardial and peripheral perfusion for any reason, as designated by Dr. Sitaram Emani's clinical judgement.
- Eligibility will be reviewed in advance by screening upcoming surgical procedures. All patients over 1 year of age will be eligible for participation in this study and screened for inclusion. Any patient at risk for malperfusion during bypass (e.g. Fontans, biventricular repair, long cross-clamp times, etc.) will be identified ahead of time and prioritized for inclusion in the study.
Key exclusion criteria (2 listed)
- Any records flagged for "research opt out."
- Neonates and children undergoing surgery less than 1 year of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue oximeter (IntraOx)The Intra.Ox device will be used to measure %StO2 readings taken at different time points during the surgery, including: (1) prior to bypass when the heart is being perfused by the coronary arteries, (2) after the patient is placed on cardiopulmonary bypass (CPB) but prior to placing a cross-clamp, (3) after placing a cross-clamp when the heart is not being perfused by CPB, and (4) after the patient is taken off CPB and the heart is re-perfusing. These readings will not impact the surgical management of the patient, and the congenital heart surgery will be carried out per standard of care according to the judgement of the surgeon. | Device | IntraOx Device Patients |
Primary outcome
Oxygen saturation
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Oxygen saturation levels measured from: pulse oximetry, tissue oximeter, arterial blood gases, and venous blood gases in units of %
Liver function test: ALP
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Post-operative liver function tests: Alkaline Phosphatase (ALP) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Liver Function Test: AST
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Post-operative liver function test: AST (Aspartate Aminotransferase) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Liver function Test: ALT
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Post-operative liver function test: ALT (Alanine Transaminase) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Cardiac function
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Measuring cardiac function as measured by ejection fraction (in %) in post-operative echocardiogram results.
Kidney function
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Laboratory values of BUN and Creatinine (Cr) in units of mg/dL as a measurement of kidney function and perfusion
Mortality and major complications
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Major complications as defined by the STS and Congenital Heart Surgeons Society including renal failure requiring dialysis, permanent neurologic deficit, pacemaker, paralyzed diaphragm, mechanical circulatory support, and unplanned reintervention. This will be recorded as one outcome (whether or not a patient had mortality and major complications) and not measuring multiple multiple assessments; it is a quantitative assessment of whether or not a patient encountered one of the major complications or mortality as defined above. There are no units of measure.
Lactate
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Lactate levels in mmol/L as measurement for tissue perfusion.
pH
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
pH from arterial blood gas and venous blood gas to measure blood acidity/alkalinity.
Blood gas: PaO2
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
PaO2 (partial pressures of oxygen) in mmHg from arterial and venous blood gas blood tests
Blood Gas: PaCO2
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
PaCO2 (partial pressures of carbon dioxide) in mmHg from arterial and venous blood gas blood tests
Bicarbonate
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Bicarbonate values from arterial and venous blood gas in units of mmol/L. This is one outcome measure that will be recorded, not multiple assessments with different units of measure. Bicarbonate values will be recorded from two different blood gas sources in mmol/L.
Echocardiography qualitative descriptions
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Measurement and recording of qualitative written report from cardiologist interpretation of echocardiography, specifically assessing for reports of 1) valvular dysfunction (regurgitation or stenosis), 2) myocardial dysfunction, hypokinesis, filling defects, etc. or 3) any other abnormalities written in qualitative report relating to cardiac function
Lactate
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Lactate levels in mmol/L as measurement for tissue perfusion
19 secondary outcomes
Intensive care unit length of stay
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Hospital length of stay
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function tests: bilirubin
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: protein
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: albumin
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: sodium
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: potassium
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: chloride
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: CO2
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Basic metabolic panel: glucose
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Basic metabolic panel: calcium
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Aortic valve diameter
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Mitral valve diameter
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Pulmonary valve diameter
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Tricuspid valve diameter
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: aortic valve
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: mitral valve
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: tricuspid valve
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: pulmonic valve
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
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 23 Jan 2026.
- Background: PubMed 30227127Pasquali SK, Shahian DM, O'Brien SM, Jacobs ML, Gaynor JW, Romano JC, Gaies MG, Hill KD, Mayer JE, Jacobs JP. Development of a Congenital Heart Surgery Composite Quality Metric: Part 1-Conceptual Framework. Ann Thorac Surg. 2019 Feb;107(2):583-589. doi: 10.1016/j.athoracsur.2018.07.037. Epub 2018 Sep 15.
- Background: PubMed 23804682Jacobs JP, Jacobs ML, Austin EH 3rd, Mavroudis C, Pasquali SK, Lacour-Gayet FG, Tchervenkov CI, Walters H 3rd, Bacha EA, Nido PJ, Fraser CD, Gaynor JW, Hirsch JC, Morales DL, Pourmoghadam KK, Tweddell JS, Prager RL, Mayer JE. Quality measures for congenital and pediatric cardiac surgery. World J Pediatr Congenit Heart Surg. 2012 Jan 1;3(1):32-47. doi: 10.1177/2150135111426732.
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- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Boston Children's Hospital.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sitaram Emani, M.D. (617-355-7932, Sitaram.Emani@CARDIO.CHBOSTON.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation (time frame: Day 0 ("baseline") up to 2 weeks post-operation). The study lists 14 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 NCT07361523, which also lists 17 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 23 Jan 2026.