PRISM: PRecision Integrated Saturation Monitor A Novel Approach to Monitoring Oxygen Saturation in Children A Prospective, Observational, Comparative Validation Clinical Study to Evaluate the Accuracy of a Novel Abdominal Pulse Oximeter With Integrated Motion Detection and Skin Tone Calibration Against Arterial Blood Gas (SaO₂) Measurements and Conventional Fingertip Pulse Oximetry (SpO₂) in Pediatric Patients.
Le Bonheur Children's Hospital
Summary
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.
Description
Conventional pulse oximeters are prone to motion artifacts due to their placement on high-activity limbs. Traditionally, inpatient pulse oximetry relies on clinical staff to verify the accuracy of readings and distinguish between real and false desaturation events. However, in outpatient environments, caregivers are left to manage and interpret signals that may not provide reliable information about their child's health. PRISM aims to improve pulse oximetry monitoring for children. We will test an innovative pulse oximeter prototype that mitigates motion artifacts by shifting the monitoring lo…
Eligibility
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * 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 movem…
Interventions
- Devicevital sign monitoring
The intervention will be to evaluate abdominal SpO2 against both traditional fingertip readings and gold standard SaO2 measurements by collecting routine data from the medical chart that was performed as standard of care.
Location
- Le Bonheur Children's HospitalMemphis, Tennessee