Can a pulse oximeter reliably track your breathing? new study aims to find out.
NCT ID NCT07449715
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checks if a new method called Respiration from Pleth (RfP) can accurately measure breathing rate using standard pulse oximeter sensors. About 113 adults and children in the hospital will have their breathing rate monitored with both the new method and a capnography device (the reference standard). The results will help improve noninvasive breathing monitoring, but no treatment or clinical decisions are based on the device outputs.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 113 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2026
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.
Who is studied
Hospitalized, spontaneously breathing adult and pediatric inpatients receiving spot-check vital-sign monitoring as part of routine clinical care, who meet all inclusion criteria and no exclusion criteria.
- Ages
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4 years and older
- 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: 1. Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent 2. UK Pediatric subjects: * Aged 16 years and older willing and able to understand and provide written informed consent * Aged 4-15 years and their legal guardians willing and able to understand and provide written informed consent/assent 3. US Pediatric Participants: aged 4 to 17 years and their parent/legal guardian are willing and able to understand and provide written informed assent/consent 4. Participant weight is within intended use of at least one SpO2 sensor under test as time of enrollment. * M1191T, adult participants \> 50 kg * M1192A, pediatric participants 15-50 kg * Nasal Alar Sensor, adult and pediatric participants ≥ 15 kg * M1194A, adult and pediatric participants \> 40 kg 5. Willing and able to wear study devices for the entirety of study procedures 6. Undergoing regular spot-check measurements as per the site's standard of care Exclusion Criteria: 1. Palliative patients 2. Patients with tremors, cardiac pacemakers, or known atrial fibrillation 3. Patients receiving oxygen supplementation at the time of study participation 4. Critically ill patients with severe physiological instability 5. Pregnant and/or lactating patients (self-reported) 6. Injury, wounds, and/or physical malformation of any sensor application site (e.g., fingers, nose, ear) 7. Self-reported severe contact allergies to standard adhesives, latex, and/or other materials found in pulse oximetry sensors 8. Unwillingness or inability to remove colored nail polish or artificial nails from the application site 9. Unwillingness or inability to remove foreign objects, such as nose and/or ear jewelry from sensor application sites 10. Nail fungus on application site 11. Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
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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
2 sites in 2 countries. 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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Duke University Hospital
RECRUITINGDurham, North Carolina, 27710, United States
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Ysbyty Gwynedd
NOT_YET_RECRUITINGBangor, Gwynedd, LL57 2PW, United Kingdom
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