Validation of Near Infrared Spectroscopy (NIRS) During Heart-Lung Bypass in Children

After patients are prospectively consented pre-operatively, standard medical care, including the use of the NIRS monitor, will be implemented during the patient's operation and post-operatively in the intensive care unit with few modifications. These modifications include: (1) the placement of an oximetric probe in the lumen of the cardiopulmonary bypass circuit tubing which will output continuous blood oxygen content during bypass, (2) the addition of extra connectors to the bypass tubing to allow blood draws during surgery, (3) placement of doppler blood flow probes on the tubing to measure blood flow velocity, and (4) the addition of LFTs during the post-operative phase, if followed. Patients that receive operations that require circulatory arrest and/or selective cerebral perfusion will be followed in the ICU for 5 days. Data from the bypass machine along, data collected from the NIRS and oximetric probe monitor, and serum data will be interfaced into a data collection system. Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), NIRS data, serum blood gas data, serum lactate levels, hemoglobin levels, vital signs, doppler blood flow data, LFT analysis, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data, and standard of care laboratory results. The investigator wishes to evaluate the relationship of this data with the patient's diagnosis, operation performed, post-operative course, and outcome. Validation of the use of the NIRS monitor and further characterization of the NIRS monitor will also be sought. Notes: 1/15/2025 -Record transferred from Ann \& Robert H Lurie Children's Hospital of Chicago to University of Texas Southwestern Medical Center since Record shows UTSW as the Sponsor. Dr. Forbess (Responsible Party) and his team for this study no longer at UTSW to shed light on why this record was transferred to Lurie Children's in 2019. Dr. Jaquiss from Cardiovascular \& Thoracic Surgery Department at UTSW confirmed on 1/7/2025 that - "No patient has been enrolled in this study and should be considered to be closed".