A Prospective, Multicenter, Randomized, Controlled, Parallel-group, Open Label Trial Evaluating Benefits of Nasal High Flow Therapy (HFT) in Preoxygenation Before Tracheal Intubation in Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 12
- 主要终点
- to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.
研究概览
简要总结
Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event.
The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure
详细描述
This study will be designed as followed : Patients will be randomized in 2 groups :"PREOXYFLOW" or "STANDARD FACE MASK".
Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction
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
- •Adults older than 18 years regardless of the gender
- •Acute hypoxemic respiratory failure defined as :
- •Respiratory rate > 30/mn AND Hypoxemia with SpO2 <90% with oxygen supply > FiO2 0,5 AND PaO2/FiO2 <300 mmHg
排除标准
- •Contraindication to oro-tracheal intubation
- •Intubation without anesthetic delivery
- •Intubation during cardiac arrest
- •Asphyxia with immediate intubation needed
- •Nasopharyngeal obstacle with contraindication to use Optiflow device
- •Patients with a documented Cormack IV exposition before inclusion
- •Protected adult
- •Pregnancy
- •Lack of consent
- •Patient already enrolled in an other randomized study.
结局指标
主要结局
to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.
时间窗: 4 minutes
This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry
次要结局
- Improvement of quality of preoxygenation(4 minutes)
- Reduction in Organ failure in the 5th day(at day 5)
- Reduction in side effects incidence related to intubation(1 hour)
- Reduction in morbi-mortality during the Intensive Care Unit stay.(until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU)