PRecision Integrated Saturation Monitor

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
Le Bonheur Children's Hospital
Study ID
NCT07686341
Status
Recruiting

Conditions

  • CHD - Congenital Heart Disease
  • Single Ventricle Heart Disease

Eligibility Criteria

Sex
ALL
Age
0 Months - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • vital sign monitoring — 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

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Abdominal SpO2 versus SaO2 [ Time Frame: From enrollment to end of study at 72 hours. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Le Bonheur Children's HospitalMemphisTennessee38105
Kara RN
901-287-4594

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