Evaluation of the FreeO2 System for Oxygen Weaning After Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Cumulative oxygen volume administered during the oxygen weaning period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
Participants assigned to the intervention group will undergo oxygen weaning using the FreeO2 automated oxygen titration system.
干预措施: FreeO2 automated oxygen titration system (Device)
Control group
Participants will undergo standard oxygen weaning according to usual clinical practice, with oxygen flow adjusted manually based on target oxygen saturation.
干预措施: Standard oxygen weaning (Other)
结局指标
主要结局
Cumulative oxygen volume administered during the oxygen weaning period
时间窗: From initiation of oxygen weaning until successful weaning (oxygen discontinuation or return to baseline oxygen requirements with stable oxygen flow for ≥4 hours).
次要结局
未报告次要终点