Taking people in United StatesNo phase
PRecision Integrated Saturation Monitor
Key facts
- Who runs it
- Le Bonheur Children's Hospital
- Where
- Memphis, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- Aug 2026
- Expected to end
- Dec 2028
- Type of study
- Observational
- Treatments tested
- vital sign monitoring
- Record updated
- 7 July 2026
Who can take part
- Age
- 0 months to 12 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Open Sternum
- Excessive movement or irritability that precludes safe and effective placement of the sensor
- Parent or legal guardian unable to provide informed consent
Where in United States
- Le Bonheur Children's HospitalMemphis, United StatesContact: Kara RNTaking people
About the trial
What the trial wants to find out
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.
Treatments tested
- vital sign monitoring
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Record updated
- 7 July 2026