PRecision Integrated Saturation Monitor
PRISM
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.
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2026
CompletedFirst Posted
Study publicly available on registry
July 7, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
July 7, 2026
June 1, 2026
2 years
June 30, 2026
June 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abdominal SpO2 versus SaO2
The primary outcome is the accuracy of abdominal SpO₂ versus SaO₂, measured as root mean square error (RMSE); target ≤ 3.0% RMSE.
From enrollment to end of study at 72 hours.
Interventions
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.
Eligibility Criteria
Eligible infants hospitalized in the intensive care unit (PICU, PCVICU,NICU) who have already had an arterial line placed and on continuous pulse oximetry monitoring will be considered for enrollment and will be identified and approached for participation during their admission.
You may qualify if:
- 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.
You may not qualify if:
- 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
- Parent or legal guardian unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MS, MD, MPH
Study Record Dates
First Submitted
June 30, 2026
First Posted
July 7, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
July 7, 2026
Record last verified: 2026-06