SpO2 Infant and Pediatric Study

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
GE Healthcare
Study ID
NCT07615738
Status
Not Yet Recruiting

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Conditions

  • SpO2
  • SpO2 (Peripheral Oxygen Saturation) Measurement Validation

Eligibility Criteria

Sex
ALL
Age
29 Days - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • SpO2 Sensor — DEVICE
    SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.

Study Details

This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years). It compares SpO₂ measurements from the device to arterial oxygen saturation (SaO₂) values from arterial CO-oximetry, and assesses the reliability of usable data, performance across skin tones, and user feedback.

Key Dates

Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: All Subjects
    Participants participating in this study will be connected to SpO2 sensors. SpO2 data will be independently collected from each sensor and paired with simultaneous arterial blood sample SaO₂ values. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.

Primary Outcome Measure

Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 values [ Time Frame: From enrollment to the end of standard of care arterial cannulation, approximately 1 week. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical Center Children's HospitalOmahaNebraska68114
Michael Facciolo, MD
[email protected]
402-671-6325
Michael Facciolo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center Children's Hospital· Omaha, NE

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