Evaluation of the FreeO2 System for Oxygen Weaning After Acute Hypoxemic Respiratory Failure

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.

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.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FreeO2 automated oxygen titration system

Device

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 weaning

Other

Oxygen flow will be adjusted manually by healthcare professionals according to usual clinical practice and predefined target oxygen saturation levels.

Primary outcomes

Cumulative oxygen volume administered during the oxygen weaning period

Time frame: From initiation of oxygen weaning until successful weaning (oxygen discontinuation or return to baseline oxygen requirements with stable oxygen flow for ≥4 hours).

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie Laurent, Clinical Research Coordinator

CONTACT

[email protected]

+33381669293

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: EVOLUERA

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Aug 31, 2026
Registry last updated: Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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