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
Qualifiers
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 design
Treatments tested in this trial
- Noninvasive hemoglobin monitoring
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Boston Children's Hospital
Lead sponsor
Becton, Dickinson and Company
Collaborator
Source ClinicalTrials.gov