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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lucie Laurent, Clinical Research Coordinator
- 電話番号：+33381669293
- メール：llaurent@chu-besancon.fr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Cumulative oxygen volume administered during the oxygen weaning period
時間枠：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).
|
協力者と研究者
捜査官
- 主任研究者：Frédéric Claudé、CHU Besançon Franche-Comté
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026/1051
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。