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

Boston Children's Hospital

Status: Not yet enrolling

Conditions: Congenital Heart Disease

Treatments: Device: Tissue oximeter (IntraOx)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07361523

IRB-P00052229

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

IntraOx Device Patients

Description:

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

Treatment:

Device: Tissue oximeter (IntraOx)