New SpO2 sensor put to the test in kids
NCT ID NCT07615738
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study will check how well a new pulse oximeter sensor works in hospitalized infants and children aged 28 days to 12 years. Researchers will compare the sensor's oxygen readings to those from a standard blood test. The goal is to see if the device is accurate, comfortable, and easy to use across different skin tones.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SpO2 sensor (device)
- What this could lead to
- If successful, this could lead to a more reliable and user-friendly pulse oximeter for monitoring oxygen levels in young patients.
- What could go wrong
- This is an early-stage device validation study, not a treatment trial. The sensor may not perform equally across all skin tones or patient conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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29 days to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Nebraska Medical Center Children's Hospital
Omaha, Nebraska, 68114, United States
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