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PRecision Integrated Saturation Monitor

RECRUITINGSponsored by Le Bonheur Children's Hospital
Actively Recruiting
SponsorLe Bonheur Children's Hospital
Started2026-08
Est. completion2028-08
Eligibility
Age0 Months – 12 Months
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 0 Months – 12 MonthsHealthy volunteers accepted
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

Conditions3

CHD - Congenital Heart DiseaseHeart DiseaseSingle Ventricle Heart Disease

Locations1 site

Le Bonheur Children's Hospital
Kara RN901-287-4594Kara.lessel@mlh.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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