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

NCT07361523 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-P00052229
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (14)

• Oxygen saturation

  Oxygen saturation levels measured from: pulse oximetry, tissue oximeter, arterial blood gases, and venous blood gases in units of %

  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

  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

  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

  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.

  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

  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.

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

• Lactate

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

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

• pH

  pH from arterial blood gas and venous blood gas to measure blood acidity/alkalinity.

  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

  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

  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.

  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

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

• Lactate

  Lactate levels in mmol/L as measurement for tissue perfusion

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

Secondary Outcomes (19)

• Intensive care unit length of stay

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

• Hospital length of stay

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

• Liver function tests: bilirubin

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

• Liver function test: protein

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

• Liver function test: albumin

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

Study Arms (1)

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

Device: Tissue oximeter (IntraOx)

Interventions

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.

IntraOx Device Patients

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital are all eligible for participation in this study.

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• ViOptix Canada: collaborator

Related Publications (17)

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• 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.

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  PMID: 27018663 BACKGROUND

• 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.

  PMID: 12270865 BACKGROUND

• 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.

  PMID: 10754077 BACKGROUND

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  PMID: 34550436 BACKGROUND

• 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.

  PMID: 33835088 BACKGROUND

• 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.

  PMID: 36971520 BACKGROUND

• 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.

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• 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.

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  PMID: 39974276 BACKGROUND

• Congenital Heart Defects: What are Congenital Heart Defects? (2022). https://www.nhlbi.nih.gov/health/congenital-heart-defects.

  BACKGROUND

• Singh Y, Lakshminrusimha S. Perinatal Cardiovascular Physiology and Recognition of Critical Congenital Heart Defects. Clin Perinatol. 2021 Aug;48(3):573-594. doi: 10.1016/j.clp.2021.05.008.

  PMID: 34353581 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI)

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share