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NCT Number: NCT07361523

Using Near-Infrared Spectroscopy Devices to Assess Myocardial and Visceral Perfusion During Complex Congenital Cardiac Surgery

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.

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Key information

Conditions

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

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Any records flagged for "research opt out."
  • Neonates and children undergoing surgery less than 1 year of age

Treatment and study plan

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.

Primary outcomes

  1. 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 %

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. Lactate

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

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

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 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

  14. Lactate

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

    Lactate levels in mmol/L as measurement for tissue perfusion

Secondary outcomes

  1. Intensive care unit length of stay

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

    Intensive care unit length of stay in days

  2. Hospital length of stay

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

    Hospital length of stay of stay in days

  3. Liver function tests: bilirubin

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

    Measurements of bilirubin in units of mg/dL to assess liver function as indicator of tissue perfusion

  4. Liver function test: protein

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

    Total protein in g/dL as measure of liver function

  5. Liver function test: albumin

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

    Albumin in g/dL as measure of liver function

  6. Electrolytes: sodium

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

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

  7. Electrolytes: potassium

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

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

  8. Electrolytes: chloride

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

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

  9. Electrolytes: CO2

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

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

  10. Basic metabolic panel: glucose

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

    Basic metabolic panel glucose levels in units of mg/dL

  11. Basic metabolic panel: calcium

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

    Basic metabolic panel calcium levels in units of mg/dL

  12. Aortic valve diameter

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

    Aortic heart valve annulus diameters measured in mm

  13. Mitral valve diameter

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

    Mitral valve annulus diameters measured in mm

  14. Pulmonary valve diameter

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

    Pulmonary valve annulus diameters measured in mm

  15. Tricuspid valve diameter

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

    Tricuspid valve annulus diameters measured in mm

  16. Heart valve pressure gradient: aortic valve

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

    Pressure gradients across aortic valve measured on echocardiography measured in mmHg

  17. Heart valve pressure gradient: mitral valve

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

    Pressure gradients across mitral valve measured on echocardiography measured in mmHg

  18. Heart valve pressure gradient: tricuspid valve

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

    Pressure gradients across tricuspid valve measured on echocardiography measured in mmHg

  19. Heart valve pressure gradient: pulmonic valve

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

    Pressure gradients across pulmonic valve measured on echocardiography measured in mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Sitaram Emani, M.D.

CONTACT

[email protected]

617-355-7932

Vivian Nguyen, B.A.

CONTACT

[email protected]

617-355-7932

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • ViOptix Canada

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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