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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Sitaram Emani, M.D. contact

617-355-7932

Sitaram.Emani@CARDIO.CHBOSTON.ORG

Vivian Nguyen, B.A. contact

617-355-7932

Vivian.Nguyen@childrens.harvard.edu

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.

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 groups in NCT07361523
Study groupRoleWhat they receive
IntraOx Device PatientsPediatric 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Lactate

    Lactate levels in mmol/L as measurement for tissue perfusion.

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Lactate

    Lactate levels in mmol/L as measurement for tissue perfusion

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

Secondary outcomes (19)

  1. Intensive care unit length of stay

    Intensive care unit length of stay in days

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  2. Hospital length of stay

    Hospital length of stay of stay in days

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  3. 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

  4. Liver function test: protein

    Total protein in g/dL as measure of liver function

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  5. Liver function test: albumin

    Albumin in g/dL as measure of liver function

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  6. Electrolytes: sodium

    Basic metabolic panel laboratory value measuring sodium in units of mEq/L

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  7. Electrolytes: potassium

    Basic metabolic panel laboratory values measuring potassium in units of mEq/L

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  8. Electrolytes: chloride

    Basic metabolic panel laboratory values measuring chloride in units of mEq/L

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  9. Electrolytes: CO2

    Basic metabolic panel laboratory values measuring CO2 in units of mEq/L

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  10. Basic metabolic panel: glucose

    Basic metabolic panel glucose levels in units of mg/dL

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  11. Basic metabolic panel: calcium

    Basic metabolic panel calcium levels in units of mg/dL

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  12. Aortic valve diameter

    Aortic heart valve annulus diameters measured in mm

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  13. Mitral valve diameter

    Mitral valve annulus diameters measured in mm

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  14. Pulmonary valve diameter

    Pulmonary valve annulus diameters measured in mm

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  15. Tricuspid valve diameter

    Tricuspid valve annulus diameters measured in mm

    Measured: Day 0 ("baseline") up to 2 weeks post-operation

  16. 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

  17. 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

  18. 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

  19. 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.

  1. First posted23 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
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 30227127

  • Jacobs 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 23804682

  • Koolen 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 27018663

  • Oskarsson 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 12270865

  • Yates 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 10754077

  • Noel 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 29748700

  • Sherwinter 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 34550436

  • Khavanin 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 33835088

  • Gonzalez-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 36971520

  • Khavanin 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 32088921

  • Nguyen 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 38939593

  • Said 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 34401838

  • Goldman 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 6333444

  • Cyran 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 2919563

  • Nguyen 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

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.

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