PRecision Integrated Saturation Monitor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorLe Bonheur Children's Hospital
About this trial
The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients. In this study, we will be collecting data from your medical record while you are being treated in the hospital for your clinical care. Your baby will be in the study for 3 days. There will be no additional study visits. We will collect information already being obtained while your baby is at the hospital.
Eligibility criteria
Qualifiers
0-12 months of age. (Must be less than 1 year of life for the pulse oximeter portion of the study) Weight greater than 2 Kg at time of study
Admitted to an intensive care unit. (Not applicable for outpatient cohort)
Arterial line in place as standard of care (Not applicable for outpatient cohort)
Informed consent provided by parent or LAR.
Disqualifiers
Open Sternum
Skin abnormalities at the proposed sensor site (e.g., rash, eczema, wounds, stoma, or infection)
Known allergy or sensitivity to adhesives or materials used in the sensor
Excessive movement or irritability that precludes safe and effective placement of the sensor
Trial design
Treatments tested in this trial
- vital sign monitoring
Treatment groups
No treatment groups listed
Sponsors and collaborators
Le Bonheur Children's Hospital
Lead sponsor
The Consortium for Technology & Innovation in Pediatrics (CTIP)
Collaborator
Source ClinicalTrials.gov