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Smart mask alarms may spot breathing trouble before it turns critical

NCT ID NCT07793981

Disease control Sponsor: Linshom Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This trial tests a new monitoring device, the Linshom CPRM, which fits into an oxygen mask or nasal cannula and alerts nurses when a patient's breathing starts to fail. Researchers will compare standard monitoring plus the Linshom alarm against standard monitoring alone in about 394 adults recovering from non-cardiac surgery. The goal is to see if the alarm system reduces the number and length of respiratory depression events, which can lead to serious complications. Nurses will respond to alarms using standard care procedures, and the trial will measure how often these events occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Linshom Continuous Predictive Respiratory Monitoring (CPRM), a device that fits into an oxygen mask or nasal cannula and alerts nurses to breathing problems
What this could lead to
If it works, this alarm system could help nurses catch breathing problems earlier after surgery, potentially preventing serious complications like respiratory arrest.
What could go wrong
This is an early-stage device trial, and it is unclear if the alarms will reduce events more than standard care. False alarms or staff response delays could limit its benefit.

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

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

About 394 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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.

Ages

18 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: * At least 18 years of age undergoing non-cardiac surgery * Post-operative patients admitted to the post-anesthesia care unit (PACU) and expected to stay in the hospital for at least overnight. * Receiving supplemental oxygen via face mask or nasal cannula in the PACU * On continuous SpO2 saturation monitoring * Receiving standard postoperative care Exclusion Criteria: * Requirement for any form of postoperative invasive ventilatory support * Patients receiving only local or topical anesthesia * Day/outpatient surgery * Unable to cooperate with the application of the study device * Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation

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Conditions

The condition(s) this trial relates to.

acute opioid poisoning Apnea respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid induced respiratory depression Post surgical respiratory failure Respiratory arrest Respiratory complication

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. 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

  • Linshom Medical, Inc.

    Baltimore, Maryland, 21230, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

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