Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics

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.

NCT Number	NCT07706140
Lead Sponsor	Boston Children's Hospital Collaborators: Becton, Dickinson and Company
Conditions	Hemoglobin, Cerebral Oxygenation, Congenital Heart Disease
Enrollment	100 participants
Start Date	2026-08
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-27