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Can a pulse oximeter reliably track your breathing? new study aims to find out.

NCT ID NCT07449715

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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.

Participants

About 113 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

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

4 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Ysbyty Gwynedd

    NOT_YET_RECRUITING

    Bangor, Gwynedd, LL57 2PW, United Kingdom

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