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.

Study Overview

• Status: Not yet recruiting
• Conditions: Evaluation of Hemoglobin Using Non Invasive Monitors; Validation of the Algorithm Used to Estimate Hemoglobin From the Cerebral Oxygen Measurements Over Time
• Intervention / Treatment: Device: Noninvasive hemoglobin monitoring

Detailed 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 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dima Daaboul, MD; Phone Number: (617) 355-1370; Email: dima.daaboul@childrens.harvard.edu
• Study Contact Backup: Name: Barry Kussman, MBBCh, FFA(SA); Phone Number: (617) 355-1370; Email: Barry.Kussman@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
      • Contact: Rachel Bernier, MPH; Phone Number: 857-218-5348; Email: rachel.bernier@childrens.harvard.edu
      • Contact: Jocelyn Booth, BSN; Phone Number: 857-218-4585; Email: jocelyn.booth@childrens.harvard.edu
      • Principal Investigator: Dima Daaboul, MD
      • Sub-Investigator: Barry Kussman, MBBCh, FFA(SA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes pediatric and adolescent patients under 21 years of age who are scheduled to undergo elective cardiac surgery or elective cardiac catheterization procedures under general anesthesia at Boston Children's Hospital. All participants will have an arterial catheter placed as part of routine clinical care and will receive standard intraoperative physiologic monitoring.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Noninvasive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Between Noninvasive and Invasive Hemoglobin Measurements	The primary outcome is the level of agreement between hemoglobin values estimated using a noninvasive near-infrared spectroscopy (NIRS)-based algorithm and reference hemoglobin values measured from arterial blood samples using standard blood-gas/co-oximetry analysis. Agreement will be assessed using measures such as bias (mean difference between paired measurements) and limits of agreement between the two methods. Results will be assessed across the observed hemoglobin range to characterize systematic error and measurement variability.	Intraoperative period (from induction of general anesthesia until end of procedure)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Becton, Dickinson and Company
• Investigators: Principal Investigator: Dima Daaboul, Boston Children's Hospital

Publications and helpful links

General Publications

• Kussman BD, Wypij D, DiNardo JA, Newburger J, Jonas RA, Bartlett J, McGrath E, Laussen PC. An evaluation of bilateral monitoring of cerebral oxygen saturation during pediatric cardiac surgery. Anesth Analg. 2005 Nov;101(5):1294-1300. doi: 10.1213/01.ANE.0000180205.85490.85.
• van Wonderen SF, Aguirre A, Benni P, van den Dool REC, Macias Pingarron JP, Solares GJ, Hatib F, Veelo DP, Vlaar APJ, Jian Z. Continuous and Noninvasive Total Blood Hemoglobin Measurement Using Near-Infrared Reflectance Spectrometry. Anesth Analg. 2025 Nov 1;141(5):1107-1115. doi: 10.1213/ANE.0000000000007618. Epub 2025 Jul 2.

Helpful Links

• Manufacturer information for the HemoSphere advanced patient monitoring platform used to acquire tissue oximetry and hemodynamic data in this study.
• Manufacturer information for the ForeSight tissue oximetry sensor, which provides continuous noninvasive cerebral tissue oxygenation monitoring and tissue hemoglobin measurements used in this study

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pediatric cardiac surgery; tissue oximetry; pediatric cardiac catheterization; transfusion guidance; noninvasive hemoglobin monitoring; near-infrared spectroscopy NIRS monitoring; ForeSight system; HemoSphere monitor; algorithm validation; arterial blood gas comparison
• Other Study ID Numbers: IRB-P00054090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The protocol does not include plans to share individual participant data with external researchers. Only deidentified data will be used by the study investigators and sponsor for study-related analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes