Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics

Conditions

• Evaluation of Hemoglobin Using Non Invasive Monitors
• Validation of the Algorithm Used to Estimate Hemoglobin From the Cerebral Oxygen Measurements Over Time

Eligibility Criteria

Sex

ALL

Age

0 Days - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Noninvasive hemoglobin monitoring — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Jul 15, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Pediatric Cardiac Surgery and Pediatric Catheterization Patients
  This cohort includes pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization under general anesthesia. All participants receive standard clinical care, including routine physiologic monitoring and arterial blood sampling when clinically indicated. As part of routine monitoring, a FDA-cleared near-infrared spectroscopy (NIRS)-based tissue oximetry system (ForeSight Tissue Oximetry System) will be placed on the forehead to continuously record cerebral tissue oxygenation during the procedure. Arterial blood samples obtained for clinical care will be analyzed using standard blood-gas/co-oximetry methods to measure blood hemoglobin levels. In select cases, a small number of additional blood samples may be collected to support data analysis. This is an observational study only. No investigational devices are used, no interventions are assigned, and there is no change to clinical management. All collected data are de-identified prior to analysis.

Primary Outcome Measure

Agreement Between Noninvasive and Invasive Hemoglobin Measurements [ Time Frame: Intraoperative period (from induction of general anesthesia until end of procedure) ]

Central Contacts

• Dima Daaboul, MD
  (617) 355-1370
  [email protected]
• Barry Kussman, MBBCh, FFA(SA)
  (617) 355-1370
  [email protected]

Locations (1)

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