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

NCT07794124 | Not Yet Recruiting

• 1 other identifier: 2026/1051
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Acute Hypoxemic Respiratory Failure; Hypoxemia

Keywords

Acute Hypoxemic Respiratory Failure; FreeO2; Oxygen Weaning; Automated Oxygen Titration

Outcome Measures

Primary Outcomes (1)

• Cumulative oxygen volume administered during the oxygen weaning period

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

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants assigned to the intervention group will undergo oxygen weaning using the FreeO2 automated oxygen titration system.

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.

Other: Standard oxygen weaning

Interventions

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.

Intervention group

Standard oxygen weaning OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• % in patients at risk of hypercapnia
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric Claudé

  CHU Besançon Franche-Comté

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucie Laurent, Clinical Research Coordinator

CONTACT

+33381669293; llaurent@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-04