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Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics

NCT07706140 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-07-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Dima Daaboul · Boston Children's Hospital

Eligibility

Min Age
0 Days
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706140 on ClinicalTrials.gov