Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-21
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Noninvasive hemoglobin monitoring
DeviceThis 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Pediatric Cardiac Surgery and Pediatric Catheterization Patients1 intervention
Trial outcomes
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).
Time frame
Intraoperative period (from induction of general anesthesia until end of procedure)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Children's Hospital
Lead sponsor
Becton, Dickinson and Company
Collaborator
Source ClinicalTrials.gov
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