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A smarter mask may spot breathing trouble before it starts

NCT ID NCT06744790

Knowledge-focused Sponsor: Linshom Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Updated 1 time

Summary

This trial tests a new monitoring device, the Linshorn CPRM, which fits into an oxygen mask and tracks breathing and oxygen levels every second. Researchers will compare its predictions with standard monitoring in 320 adults recovering from non-cardiac surgery in the post-anesthesia care unit. The goal is to see if the device can warn nurses earlier when a patient's breathing is about to decline, giving them more time to intervene.

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 Monitor (CPRM), a device that tracks breathing and oxygen levels through a face mask sensor
What this could lead to
If it works, this could give nurses an early warning system to spot breathing trouble after surgery before it becomes serious, potentially preventing emergencies.
What could go wrong
This is an observational study, so it does not test a treatment. The monitor may not prove more accurate than standard care, and results depend on how well it performs in real hospital settings.

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

320 people

The number who actually took part.

Started

Jun 2023

Finished

Jun 2025

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

This study will be conducted at The University of Maryland Medical Center (UMMC) where about 9% of the surgical procedures will go to the ICU or other non-PACU location and 20% will go home same day (within 24 hours). Based on previous trial data from UMMC, investigators expect gender to be \~50% male, 76% white and 23% non-white with an age distribution of 1/3 \< 60 years of age and 2/3 \> 60 years of age. This enrollment criteria makes the study results generalizable; population balanced and supports enrollment.

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: * ≥18 years old undergoing non-cardiac surgery * Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight * Receiving supplemental oxygen via face mask in the PACU * On continuous SpO2 saturation monitoring * Receiving standard postoperative of 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.

respiratory failure

As listed by the trial registrant

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

Post surgical respiratory failure Respiratory complication

Contacts and locations

Locations

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.