An Adaptive Randomized Controlled Trial (RCT) Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected Intensive Care Unit Patients Admitted for Hypoxemic Acute Respiratory Failure: The KISS Trial (Key Oxygenation Interventions in Surgical and Non-Surgical Patients)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,470
- 试验地点
- 2
- 主要终点
- Day-28 mortality
研究概览
简要总结
The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.
详细描述
This randomized controlled trial is a superiority study to test if one of the methods (NIV and/or HFNO) is superior to standard oxygen in ARF patients requiring oxygen. It is an investigator-initiated, multicenter, adaptive, three arms parallel-group trial with a computer-generated allocation sequence and an electronic system-based randomization, with a stratification on medical (then stratification between immunocompromised and non-immunocompromised patients) versus surgical (then stratification between cardiothoracic and abdominal patients).
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
- •Adult (age ≥ 18 years)
- •A diagnosis of hypoxemic ARF occurring defined as the presence and persistence for more than 30 minutes of hypoxemia (defined by a partial oxygen pressure <60 mm Hg when breathing room air or <80 mmHg when breathing 15 L/min of oxygen or a peripheral oxygen saturation [SpO2] ≤90% when breathing room air and/or a PaO2(partial pressure of oxygen)/FiO2 ratio < 300 mmHg plus either [1] a respiratory rate higher than 30/min or [2] clinical signs suggestive of intense respiratory muscle work and/or labored breathing, such as use of accessory respiratory muscles, paradoxical motion of the abdomen, or intercostal retraction).
排除标准
- •Contraindications to NIV and/or HFNO
- •Sleep apnea syndrome with home ventilator
- •Immediate tracheal intubation
- •Requirement for an emergent surgical procedure requiring intubation
- •Hypercapnia with a formal indication for NIV (formal indication for NIV with PaCO2 ≥ 50 mmHg or clinical signs of hypercapnia)
- •Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
- •Anatomical factors precluding the use of NIV and/or HFNO
- •Patients with limitation or withdrawal of life-sustaining therapies with a do-not-intubate order
- •Pregnancy in progress or planned during the study period or breastfeeding women
- •Patients protected by law (Art. L1121-6 and L1121-8 of the Code de la Santé Publique): Adult protected by law or patient under guardianship or curatorship
- •Subjects not covered by public health insurance
- •Absence of written informed consent from the patient or his or her proxy (if present) before inclusion or when possible when the patient has been included in an emergency setting
研究组 & 干预措施
High-Flow nasal cannula therapy (HFNO)
Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator.
干预措施: HFNO (Procedure)
Noninvasive ventilation therapy (NIV)
Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group.
干预措施: NIV (Procedure)
Standard oxygen therapy
Patients will receive standard oxygen. First attempt device in usual care.
干预措施: Standard oxygen (Procedure)
结局指标
主要结局
Day-28 mortality
时间窗: Up to Day-28
Mortality rates at Day-28
次要结局
- Intubation rate at Day-28(Day-28)
- Intubation rate at Day-3(Day-3)
- Intubation rate at Day-7(Day-7)
- Oxygenation up to Day-7(Up to Day-7)
- Need of other rescue oxygen therapy up to Day-7(Up to Day-7)
- ICU length of stay(Up to Day-90)
- Hospital length of stay(Up to Day-90)
- Mortality rates in ICU(Up to Day-90)
- Mortality rates in hospital(Up to Day-90)
- Day-90 mortality(Day-90)
- Adverse events(Up to Day-90)