NCT07686341 · Le Bonheur Children's Hospital
PRecision Integrated Saturation Monitor
(PRISM)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
vital 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.
Primary outcome measures
Abdominal SpO2 versus SaO2
Time frame: From enrollment to end of study at 72 hours.
The primary outcome is the accuracy of abdominal SpO₂ versus SaO₂, measured as root mean square error (RMSE); target ≤ 3.0% RMSE.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 movement or irritability that precludes safe and effective placement of the sensor
- Parent or legal guardian unable to provide informed consent
Where
- Memphis, Tennessee
Collaborators
The Consortium for Technology & Innovation in Pediatrics (CTIP)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations