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NOT YET RECRUITING
NCT07794124
NA

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

Sponsor: Centre Hospitalier Universitaire de Besancon

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09-15

Completion Date

2028-01-01

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

DEVICE

FreeO2 automated oxygen titration system

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.

OTHER

Standard oxygen weaning

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