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Smart oxygen device aims to keep COPD and surgery patients breathing easier

NCT ID NCT04136717

Symptom relief Sponsor: François Lellouche Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a device called FreeO2 that automatically adjusts oxygen levels during noninvasive breathing support. It includes 10 patients with COPD flare-ups or after weight-loss surgery. The goal is to see if the device keeps oxygen in a safe range better than manual adjustments.

What this could mean

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

Active substance
FreeO2 automatic oxygen titration device
What this could lead to
If it works, this device could help patients maintain safer oxygen levels during breathing support, reducing risks of too little or too much oxygen.
What could go wrong
This is a very small, early-stage study with only 10 participants, so results may not apply broadly. The device may not improve outcomes or could cause discomfort.

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 10 people

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

Started

Oct 2019

Expected to finish

Jun 2028

An estimate. End dates often move.

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 (AECOPD): * Respiratory acidosis (pH \<= 7.35 and PaCO2 \> 45 mmHg), with or without NIV (last blood gas available during hospitalization) * Oxygen therapy and/or SpO2 \<90% room air (FiO2 \<= 50% or nasal cannula \<= 7 L/min to maintain SpO2 90%) * High flow nasal cannula with flow \<= 30 L/min Inclusion Criteria (Bariatric surgery post-op): * Patients using CPAP before the surgery (obstructive sleep apnea documented). * Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included. Exclusion Criteria: * Age \< 18 * Pregnancy * Respiratory distress or other clinical situation requiring continuous NIV or CPAP * Glasgow \< 12 or agitation/delirium/dementia (limiting NIV) * Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery) * Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes) * Refusal to consent to the study 5 patient with AECOPD and 5 patient with bariatric surgery will be included.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease Obesity, Abdominal obesity-hypoventilation syndrome obstructive sleep apnea syndrome

As listed by the trial registrant

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

Abdominal obesity COPD exacerbation Oxygen toxicity Surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Institut universitaire de Cardiologie et de Pneumologie - Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

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