About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Acute hypoxemic respiratory failure requiring high-flow nasal oxygen therapy for at least 12 hours
Fraction of inspired oxygen (FiO₂) ≤35%
88% in patients at risk of hypercapnia
Disqualifiers
Age <18 years
Uncontrolled acute respiratory acidosis requiring invasive or non-invasive mechanical ventilation
Unstable peripheral oxygen saturation (SpO₂)
Excessive bronchial secretions
Trial design
Parallel
Treatments tested in this trial
FreeO2 automated oxygen titration system
DeviceThe 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 interventionOxygen flow will be adjusted manually by healthcare professionals according to usual clinical practice and predefined target oxygen saturation levels.
Treatment groups
Trial outcomes
Primary outcomes
Cumulative oxygen volume administered during the oxygen weaning period
Locations
Sponsors and contacts
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