Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Oxygenation failure
研究概览
简要总结
In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.
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 over 18 years.
- •Admission to ICU for ARF. ARF was defined with the need of oxygen over 6l/min to maintain SpO2 over 95% or symptom of respiratory distress (intercostal recession or tachypnea >30/min or dyspnea at rest).
- •Immunosuppression. Immunosuppressed conditions were solid tumor, hematological malignancy, steroid treatment or other immunosuppressive treatment, or HIV infection.
排除标准
- •Hypercapnia (above 47 mmHg)
- •Chronic respiratory failure
- •Previous mechanical ventilation in the days before admission
- •Need of immediate NIV or intubation
- •Pregnancy
研究组 & 干预措施
Venturi group
Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%.
干预措施: Venturi mask (Device)
Venturi group
Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%.
干预措施: Oxygen (Drug)
HFNC group
HFNC group : Oxygen is delivered using HFNC. HFNC is started with FIO2 =1 and modified to maintain SpO2 over 94%, flow is settled at 40-50l/min.
干预措施: High Flow Nasal Canula (HFNC) (Device)
HFNC group
HFNC group : Oxygen is delivered using HFNC. HFNC is started with FIO2 =1 and modified to maintain SpO2 over 94%, flow is settled at 40-50l/min.
干预措施: Oxygen (Drug)
结局指标
主要结局
Oxygenation failure
时间窗: 2 hours
Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period
次要结局
- comfort (0-10 Visual analog Scale)(2 hours)
- thirst (0-10 Visual analog Scale)(2 hour)
- dyspnea (0-10 Visual analog Scale)(2 hour)