Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics

NCT07706140 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-P00054090
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemoglobin; Cerebral Oxygenation; Congenital Heart Disease

Keywords

pediatric cardiac surgery; pediatric cardiac catheterization; transfusion guidance; noninvasive hemoglobin monitoring; near-infrared spectroscopy NIRS monitoring; tissue oximetry; ForeSight system; HemoSphere monitor; algorithm validation; arterial blood gas comparison

Outcome Measures

Primary Outcomes (1)

• Agreement Between Noninvasive and Invasive Hemoglobin Measurements

  The primary outcome measure is the agreement between NIRS-estimated hemoglobin and hemoglobin measured from arterial blood samples. Both assessments measure hemoglobin concentration and will be reported in grams per deciliter (g/dL). Agreement will be assessed by comparing paired hemoglobin measurements from the two methods. The reported outcome will include the mean difference between the two measurements (g/dL) and the range of differences observed (g/dL).

  Intraoperative period (from induction of general anesthesia until end of procedure)

Study Arms (1)

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

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.

Pediatric Cardiac Surgery and Pediatric Catheterization Patients

Eligibility Criteria

• Age: 0 Days - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Age less than 21 years at the time of enrollment.
• Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia.
• Placement of an arterial catheter as part of routine clinical care for the procedure.

You may not qualify if:

• Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality.
• Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 16243983 BACKGROUND

• 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.

  PMID: 40601488 BACKGROUND

Related 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

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dima Daaboul

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dima Daaboul, MD

CONTACT

(617) 355-1370; dima.daaboul@childrens.harvard.edu

Barry Kussman, MBBCh, FFA(SA)

CONTACT

(617) 355-1370; Barry.Kussman@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)