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Smart oxygen machine aims to get COPD patients out of hospital faster

NCT ID NCT03835741

Disease control Sponsor: Laval University 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a device called FreeO2 that automatically adjusts oxygen levels for people hospitalized with a COPD flare-up. The goal was to see if it could shorten hospital stays compared to manual oxygen adjustment by staff. Only 17 people took part, and the study was stopped early, so we don't have clear answers yet.

What this could mean

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

Active substance
FreeO2 device (automated oxygen adjustment)
What this could lead to
If it works, this could reduce hospital stays for COPD flare-ups by automatically adjusting oxygen levels.
What could go wrong
The trial was terminated early and enrolled only 17 people, so results are very limited. Automated oxygen may not work better than standard manual care.

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

17 people

The number who actually took part.

Started

Dec 2018

Finished

Jul 2024

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: * COPD or suspected COPD ( Age\>40, active or smoking history \> 10pack/years), - * Acute exacerbation (increasing dyspnea recently) * One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea, * Moderate oxygen therapy: Oxygen flow \< 8 lpm (or FiO2 \< 0.60) to maintain a SpO2 \>or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 \> or = 92%) Exclusion Criteria: * Patient refusal * COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose * No SpO2 signal * Encephalopathy score \> 2 * Delirium * Other respiratory support needed (intubation or NIV) * Patient on withdrawal life support * Advance neoplasia (palliative stage) or terminal respiratory distress * Unavailability of FreeO2 device at the randomisation * Non optimal patient collaboration

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease Hyperoxia Hypoxia respiratory failure

As listed by the trial registrant

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

COPD exacerbation Hyperoxia Hypoxemia Hypoxic respiratory failure Oxygen toxicity

Contacts and locations

Locations

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec, G1V4G5, Canada

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