Back to search results

SpO2 Sensor Study for Infants and Children

This study is evaluating a new SpO2 (pulse oximetry) sensor, which measures the oxygen levels in your child's blood. We want to see how well this sensor works in hospitalized infants (1-23 months old) and children (2-12 years old). The study will compare the sensor's readings to oxygen levels measured directly from arterial blood samples, which your child would already be getting as part of their regular care. We're also looking at how reliable the sensor is and how well it works on different skin tones. The goal is to make sure the sensor provides accurate and useful information for doctors and nurses.

Study design
This is an interventional study planning to enroll 180 participants, including infants and children.
What's involved
Your child would have SpO2 sensor data collected at the same time as their routine arterial blood samples, for approximately one week.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment until the end of standard of care arterial cannulation, approximately one week.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07615738

SpO2 Infant and Pediatric Study

Not Yet Recruiting
NAAges 29–12InterventionalDevice feasibility
GE Healthcare
~180 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:SpO2 Sensor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 values
Measured over From enrollment to the end of standard of care arterial cannulation, approximately 1 week.

Conditions

SpO2 (Peripheral Oxygen Saturation) Measurement Validation
SpO2

Explore related trials

ChildrenInfants

NCT07615738

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Nebraska Medical Center Children's Hospital

    Omaha, Nebraskastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Michael Facciolo, MD
[email protected]
402-671-6325
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

subjects are 1-23 months (infant cohort) or 2-12 years old (child cohort)
requiring arterial blood samples per the site's standard of care.

Exclusion

Fractional Methemoglobinemia (FMetHb \>2%) or Fractional carboxyhemoglobinemia (FCOHb \>3%), within 24 hours of arterial blood draw.
Severe anemia (tHb \<7g/dL) within 4 hours prior to arterial blood gas draw.
Hematocrit (Hct) \<25 within 4 hours prior to arterial blood gas draw.
Patients with injuries, deformities, or abnormalities which may prevent proper application of the sensor.
Patients on Extracorporeal Membrane Oxygenation (ECMO).
Patients receiving point of care (POC) testing for blood gases.
Patients with diseases/conditions that may cause differential (or reverse differential) cyanosis including, but not limited to:
Patent ductus arteriosus with pulmonary arterial hypertension.
Pulmonary hypertension and left-heart abnormalities aortic arch hypoplasia, interrupted aortic arch, critical coarctation, and critical aortic stenosis.
Children with transposition of the great arteries (TGA) and coarctation of the aorta or interrupted aortic arch, and TGA with suprasystemic pulmonary vascular resistance.
At the discretion of the principal investigator or designee due to the subject health condition.

What this trial measures

  • Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 valuesFrom enrollment to the end of standard of care arterial cannulation, approximately 1 week.

    The collection of SpO2 percentage sensor data with simultaneous SaO2 values percentage from each subject enrolled in the study.