Prospective Observational Data Collection Study for Validation of a Near-Infrared Spectroscopy-Based Blood Hemoglobin Algorithm in Pediatric Patients Undergoing Cardiac Surgery or Cardiac Catheterization
Boston Children's Hospital
Summary
This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin measurements obtained from blood samples that are already being collected as part of routine medical care. The goal of the study is to determine whether a blood hemoglobin monitoring method that has already been cleared by the U.S. Food and Drug Administration (FDA) for use in adults may also work well in pediatric patients.
Description
Background: Continuous monitoring of blood hemoglobin levels may help clinicians identify changes in a patient's blood status during surgery and support decisions regarding blood transfusion. A noninvasive blood hemoglobin monitoring method has been developed using near-infrared spectroscopy (NIRS) technology incorporated into the ForeSight Tissue Oximetry System. This technology uses near-infrared light to measure tissue oxygenation and derive information related to blood hemoglobin levels. An algorithm based on these measurements has been validated and cleared by the U.S. Food and Drug Admi…
Eligibility
- Age range
- 0–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age less than 21 years at the time of enrollment. 2. Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia. 3. Placement of an arterial catheter as part of routine clinical care for the procedure. Exclusion Criteria: 1. Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality. 2. Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.
Interventions
- DeviceNoninvasive hemoglobin monitoring
This study evaluates noninvasive hemoglobin monitoring using a near-infrared spectroscopy (NIRS)-based tissue oximetry system in pediatric patients undergoing cardiac surgery or cardiac catheterization under general anesthesia. A FDA-cleared ForeSight Tissue Oximetry sensor is placed on the forehead to continuously measure tissue oxygenation, and an algorithm is derived to estimate hemoglobin. Reference hemoglobin values are obtained from arterial blood samples analyzed using standard blood-gas/co-oximetry methods as part of routine clinical care. A small number of additional samples may be collected if needed. The study compares noninvasive hemoglobin estimates with laboratory hemoglobin measurements. No investigational devices are used, and there is no change to clinical care.
Location
- Boston Children's HospitalBoston, Massachusetts