Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics

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

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.

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 Administration (FDA) for use in adult patients.

Study Purpose:

The purpose of this study is to collect synchronized physiologic and laboratory data from pediatric patients to evaluate the feasibility and performance of applying an FDA-cleared adult blood hemoglobin algorithm to pediatric populations. The study will compare hemoglobin values estimated by the algorithm with reference hemoglobin values measured from arterial blood samples using standard blood-gas/co-oximetry analysis.

Study Design:

This is a prospective observational study conducted at Boston Children's Hospital. Pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization procedures under general anesthesia will be eligible for participation. No investigational devices will be used, and participation in the study will not alter routine clinical care.

Study Procedures:

Following enrollment and informed consent, ForeSight tissue oximetry sensors will be placed on the patient's forehead as part of routine monitoring. One or two sensors may be used depending on patient size and available forehead surface area. The sensors will remain in place during the procedure and will continuously record tissue oxygenation and related physiologic signals.

Arterial blood samples obtained as part of routine clinical care will be used to measure blood hemoglobin levels using a blood-gas/co-oximetry analyzer. In some patients, up to two additional blood samples may be collected to strengthen the evaluation dataset. The amount of blood collected for these additional samples will be minimal.

Additional data collected will include demographic information, procedure type, standard physiologic monitoring parameters (such as heart rate, blood pressure, oxygen saturation, respiratory measurements, and temperature), laboratory values, administered medications and blood products, and clinically significant hemodynamic events documented during the procedure.

Data Handling:

Data collected from the monitoring system and clinical records will be linked and subsequently de-identified by authorized study personnel. Personal identifiers will be removed before data are shared with the study sponsor. The sponsor will have access only to de-identified study data.

Outcome Evaluation:

The primary objective is to assess the agreement between hemoglobin values estimated by the NIRS-based algorithm and reference hemoglobin values measured from arterial blood samples. Study analyses will evaluate the accuracy, bias, precision, and agreement of algorithm-derived hemoglobin measurements in pediatric patients. The results will help determine whether the adult FDA-cleared algorithm performs adequately in pediatric populations and will provide information to guide future clinical evaluation and regulatory activities related to noninvasive hemoglobin monitoring in children and adolescents.

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.