What this study is
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.
What's being tested
- vital sign monitoring
Intervention · DEVICE
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.
Study details
- 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.
- Sponsor
- Le Bonheur Children's Hospital
- Conditions
- CHD - Congenital Heart Disease · Single Ventricle Heart Disease
- Enrolling
- 100 people
- Starts
- 2026-08
- Est. completion
- 2028-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Months – 12 MonthsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLe Bonheur Children's Hospital
Memphis, Tennessee, United States
- Kara RN · Contact901-287-4594Kara.lessel@mlh.org
Recruiting
Study team
Sponsor
Le Bonheur Children's Hospital
Study ID STUDY00000178
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.