Evaluation of the FreeO2 System for Oxygen Weaning After Acute Hypoxemic Respiratory Failure (EVOLUERA)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Lucie Laurent, Clinical Research Coordinator
- Telefonnummer: +33381669293
- E-Mail: llaurent@chu-besancon.fr
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention group
Participants assigned to the intervention group will undergo oxygen weaning using the 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.
|
|
Aktiver Komparator: Control group
Participants will undergo standard oxygen weaning according to usual clinical practice, with oxygen flow adjusted manually based on target oxygen saturation.
|
Oxygen flow will be adjusted manually by healthcare professionals according to usual clinical practice and predefined target oxygen saturation levels.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Cumulative oxygen volume administered during the oxygen weaning period
Zeitfenster: From initiation of oxygen weaning until successful weaning (oxygen discontinuation or return to baseline oxygen requirements with stable oxygen flow for ≥4 hours).
|
From initiation of oxygen weaning until successful weaning (oxygen discontinuation or return to baseline oxygen requirements with stable oxygen flow for ≥4 hours).
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Frédéric Claudé, CHU Besançon Franche-Comté
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026/1051
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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