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Can a smart oxygen device outperform manual care in recovery?

NCT ID NCT07794124

Disease control Sponsor: Centre Hospitalier Universitaire de Besancon Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This trial tests whether an automated oxygen titration system, called FreeO2, can improve oxygen weaning in patients recovering from acute hypoxemic respiratory failure. The device continuously adjusts oxygen flow based on oxygen saturation levels, potentially reducing episodes of too little or too much oxygen. Researchers will compare it to standard manual oxygen adjustment in 40 adults who have used high-flow nasal oxygen for at least 12 hours. The goal is to see if the device improves oxygen control and makes the weaning process smoother.

What this could mean

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

Active substance
FreeO2 automated oxygen titration system
What this could lead to
If it works, this could make oxygen weaning safer and more efficient, reducing time on oxygen and improving patient outcomes.
What could go wrong
The trial is small and early, and the device may not show a clear benefit over manual adjustment. There is also a risk of device malfunction or inaccurate readings.

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 40 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 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: * Age ≥18 years * Acute hypoxemic respiratory failure requiring high-flow nasal oxygen therapy for at least 12 hours * Fraction of inspired oxygen (FiO₂) ≤35% * Peripheral oxygen saturation (SpO₂) ≥ the predefined lower target threshold: * 88% in patients at risk of hypercapnia * 94% in patients without risk of hypercapnia * Women of childbearing potential must use an effective contraceptive method (oral contraceptives, injectable contraceptives, intrauterine device, double-barrier method, contraceptive patch); women must be postmenopausal for at least 24 months or surgically sterilized * Patient's oral agreement and absence of written refusal to participate, indicating that the participant has understood the study objectives and required procedures and agrees to participate and comply with study-related requirements and restrictions * Affiliation with or beneficiary of the French social security system Exclusion Criteria: * Age \<18 years * Uncontrolled acute respiratory acidosis requiring invasive or non-invasive mechanical ventilation * Unstable peripheral oxygen saturation (SpO₂) * Excessive bronchial secretions * Carbon monoxide poisoning * Severe cardiocirculatory failure (mean arterial pressure \<65 mmHg without fluid resuscitation and/or requiring vasopressors, and/or severe arrhythmia) * Acute neurological failure (Glasgow Coma Scale \<15, or new-onset sensorimotor deficit) * Acute kidney injury requiring renal replacement therapy * Known untreated severe obstructive sleep apnea

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Conditions

The condition(s) this trial relates to.

acute respiratory failure Hypoxia respiratory failure

As listed by the trial registrant

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

Acute hypoxemic respiratory failure Hypoxemia

How to take part

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  1. The official record

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