Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Smart oxygen machine could prevent dangerous levels in hospital patients

NCT ID NCT06374225

Disease control Sponsor: University of Colorado, Denver 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device that automatically adjusts oxygen levels for hospitalized patients with serious injuries or illnesses. 300 adults received either the automated device or standard manual oxygen adjustments. The goal was to see if the device kept oxygen levels in a safer range (90-96%) during the first 72 hours of care.

What this could mean

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

Active substance
Automated oxygen titration device (O2matic PRO100)
What this could lead to
If successful, this device could help hospitals keep patients' oxygen levels in a safer range automatically, reducing complications from too much or too little oxygen.
What could go wrong
This is a completed trial with 300 participants, but results may not apply to all patients or settings. The device may not improve outcomes like survival or length of stay.

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

300 people

The number who actually took part.

Started

Apr 2024

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age 18 years or older * Hospitalized or will be hospitalized from Emergency Department for major trauma, burn, acute care surgery, or acute respiratory illness * Able to be randomized within 36 hours of hospital arrival * Receiving supplemental oxygen 1-10 liters per minute for documented or presumed hypoxemia (must be higher than baseline for those on chronic oxygen therapy) * Signed and dated informed consent from patient or legally authorized representative (LAR) Exclusion Criteria: * Anticipated hospital discharge within 24 hours * Imminent plans to discontinue supplemental oxygen * Imminent plans to administer high flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation * Clinical team unwilling or unable to follow the prescribed oxygen titration method in either randomized group * Known prisoner * Known pregnancy * Known contraindicated conditions for use of the PRO100 device: carbon monoxide poisoning, incapable of handling airway secretions, increased methemoglobin, cyanide poisoning, cluster headaches, undrained pneumothorax, sickle cell crisis, paraquat poisoning or a history of bleomycin poisoning, patients for whom the SpO2 signal is not stable

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Critical illness are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

burn Critical Illness Disease Attributes Hyperoxia Hypoxia injury Pathologic Processes

As listed by the trial registrant

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

Critical illness Disease attributes Pathologic processes Wounds and injury

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Oregon Health and Sciences University

    Portland, Oregon, 97239, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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