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

Overview

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.

Interventions

• Device 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 manag

Primary outcome measures

• Oxygen saturation [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Liver function test: ALP [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Liver Function Test: AST [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Liver function Test: ALT [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Cardiac function [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Kidney function [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Mortality and major complications [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Lactate [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• pH [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]
• Blood gas: PaO2 [Time frame: Day 0 ("baseline") up to 2 weeks post-operation]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33835088

Identifiers

NCT: NCT07361523 · IRB-P00052229

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗