Safety and Efficacy of a Closed-loop Oxygen Control for High Flow Nasal Therapy in ICU Patients: a Randomized Cross-over Study (The HILOOP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Percentage of time spent in optimal SpO2 range
研究概览
简要总结
In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decrease work of breathing as compared to standard oxygen therapy by facemask. Current guidelines recommend adjusting oxygen flow rates to keep the oxygen saturation measured by pulse oximetry (SpO2) in the target range and avoid hypoxemia and hyperoxemia. The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ICU patients treated with HFNT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult (>17yo) patients admitted to the ICU treated with HFNT for at least 8h
- •Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician
- •Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation.
排除标准
- •Patient with indication for immediate continuous positive airway pressure (CPAP), noninvasive ventilation (NIV), or invasive mechanical ventilation
- •Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
- •Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange colour bar)
- •Severe acidosis (pH ≤ 7.30)
- •Pregnant woman
- •Patients deemed at high risk for need of mechanical ventilation within the next 8 hours
- •Chronic or acute dyshemoglobinemia: methemoglobin, carbon monoxide (CO) poisoning, sickle cell disease
- •Tracheotomised patient
- •Formalized ethical decision to withhold or withdraw life support
- •Patient under guardianship
- •Patient deprived of liberties
- •Patient included in another interventional research study under consent
- •Patient already enrolled in the present study in a previous episode of acute respiratory failure
结局指标
主要结局
Percentage of time spent in optimal SpO2 range
时间窗: 4 hours
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
次要结局
- Percentage of time spent out of range(4 hours)
- Percentage of time spent in sub-optimal SpO2 range(4 hours)
- Percentage of time with SpO2 signal available(4 hours)
- Mean SpO2/FiO2(4 hours)
- ROX index(4 hours)
- Percentage of time with SpO2 below 88 and 85 percent(4 hours)
- Number of events with SpO2 below 88 and 85 percent(4 hours)
- Mean FiO2(4 hours)
- Percentage of time with FiO2 below 40 percent and above 60%(4 hours)
- Number of manual adjustments(4 hours)
- Number of alarms(4 hours)
- Patient comfort(4 hours)