Acute Hypoxemic Respiratory FailureEVOLUERANCT07794124
Evaluation of the FreeO2 System for Oxygen Weaning After Acute Hypoxemic Respiratory Failure
A study testing FreeO2 automated oxygen titration system and Standard oxygen weaning in people with Acute Hypoxemic Respiratory Failure and Hypoxemia, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Acute hypoxemic respiratory failure (AHRF) is a common condition associated with substantial morbidity, mortality, and healthcare resource utilization. Although advances in oxygen therapy, particularly high-flow nasal oxygen (HFNO), have improved the management of AHRF, the transition from HFNO to conventional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, Hypoxemia
- What is being tested?
- FreeO2 automated oxygen titration system and Standard oxygen weaning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Acute hypoxemic respiratory failure (AHRF) is a common condition associated with substantial morbidity, mortality, and healthcare resource utilization. Although advances in oxygen therapy, particularly high-flow nasal oxygen (HFNO), have improved the management of AHRF, the transition from HFNO to conventional low-flow oxygen therapy remains an important and understudied phase of patient care.
During oxygen weaning, oxygen flow is usually adjusted manually by healthcare professionals according to a target oxygen saturation (SpO₂). Because oxygen saturation is often assessed intermittently outside continuously monitored settings, patients may experience episodes of hypoxemia or hyperoxia before oxygen flow is adjusted.
Read more
FreeO2 is an automated oxygen titration system that continuously adjusts oxygen flow according to the patient's SpO₂. Its safety and effectiveness have been demonstrated in several clinical settings, but its use during oxygen weaning after HFNO has not been specifically evaluated.
The objective of this study is to assess whether the use of the FreeO2 system during oxygen weaning after HFNO in patients recovering from acute hypoxemic respiratory failure improves oxygen saturation control and facilitates the weaning process compared with standard oxygen therapy.
- Conditions
- Acute Hypoxemic Respiratory Failure, Hypoxemia
- Being tested
- FreeO2 automated oxygen titration system, Standard oxygen weaning
- Keywords
- Acute Hypoxemic Respiratory Failure, FreeO2, Oxygen Weaning, Automated Oxygen Titration
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeO2 automated oxygen titration systemDevice
The FreeO2 system is an automated oxygen titration device that continuously adjusts oxygen flow according to the patient's peripheral oxygen saturation (SpO₂). In this study, the device will be used during oxygen weaning after high-flow nasal oxygen therapy in patients recovering from acute hypoxemic respiratory failure.
Standard oxygen weaningOther
Oxygen flow will be adjusted manually by healthcare professionals according to usual clinical practice and predefined target oxygen saturation levels.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants assigned to the intervention group will undergo oxygen weaning using the FreeO2 automated oxygen titration system. Receives: Device: FreeO2 automated oxygen titration system |
| Control group | Active comparator | Participants will undergo standard oxygen weaning according to usual clinical practice, with oxygen flow adjusted manually based on target oxygen saturation. Receives: Other: Standard oxygen weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative oxygen volume administered during the oxygen weaning period
Measured: From initiation of oxygen weaning until successful weaning (oxygen discontinuation or return to baseline oxygen requirements with stable oxygen flow for ≥4 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Claudé, Principal investigator, CHU Besançon Franche-Comté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794124
- Sponsor's protocol ID
- 2026/1051
- Acronym
- EVOLUERA
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided