Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of severe hypoxemia
研究概览
简要总结
The aim of this clinical study is to assess whether apneic oxygenation with High-Flow Nasal Oxygen (HFNO) would decrease the incidence of severe hypoxemia compared to no apneic oxygenation during the intubation procedure (from the start of laryngoscopy to 5 minutes after successful intubation) in patients with hypoxemic acute respiratory failure.
The sponsor expects that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.
Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:
Experimental group : Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).
non-invasive ventilation (NIV) alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.
At the time of laryngoscopy: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
Control group: The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.
详细描述
Endotracheal intubation is often performed in intensive care unit (ICU). Severe complications (such as severe hypoxemia, hypotension, cardiac arrest) occur up to 50%. Severe hypoxemia is more frequent in patients with hypoxemia prior to intubation or during difficult intubation and could increase the risk of cardiac arrest.
The procedure of intubation includes, in order 1) a preoxygenation phase ending with iv administration of anesthetic drugs 2) a hypoventilation phase 3) an apneic phase beginning with laryngoscopy and ending with successful intubation 4) mechanical ventilation. Optimization of this procedure is essential.
Non-invasive ventilation (NIV) is recommended for preoxygenation in hypoxemic patients and this technique can maintain ventilation during the hypoventilation phase.
Apneic oxygenation is defined as the administration of oxygen during the apneic phase. The objective is to increase the duration of apnea without desaturation. In physiological studies and in the operating room, when apneic oxygen is used with standard oxygen (up to 15L/min) or high-flow nasal oxygenation (HFNO) (up to 70L/min and FiO2 at 1.0), the apnea length without desaturation can reach several minutes.
Several meta-analyses (with high heterogeneity between studies) found that apneic oxygenation (including standard oxygen or HFNO) in emergency intubation could decrease the risk of hypoxemia. In most studies that investigated the effect of HFNO as apneic oxygenation, HFNO was also used as a preoxygenation method. Thus, the different methods of preoxygenation could affect the real effect of apneic oxygenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patient admitted in the ICU
- •Indication of orotracheal intubation for Hypoxemic acute respiratory failure defined by:
- •One sign of acute respiratory distress (respiratory rate >25/min, dyspnea or the use of accessory respiratory muscle)
- •AND a PaO2/FiO2 ≤ 200 mmHg (measured or calculated FiO2) within 6 hours before the decision of intubation. For the calculation of FiO2, the FiO2 will be estimated by: FiO2 = 0.21 + 0.03 x (flow of oxygen) (Coudroy, Thorax 2020)
- •Informed consent from the patient or relatives. An emergency procedure will be possible when necessary.
排除标准
- •< 18 years old
- •Need for emergent intubation (i.e. cardiac arrest)
- •Contraindication to non-invasive ventilation for preoxygenation
- •Known allergy or contraindication to one of the induction drugs
- •SpO2 device specific for the study not available
- •Patients without any healthcare insurance scheme or not benefiting from it through a third party,
- •Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision
- •Previous participation in the study
研究组 & 干预措施
Experimental group
Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).
NIV alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy.
Apneic oxygenation will be used with HFNO at the time of laryngoscopy after removing the facemask of NIV (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0)
干预措施: Apneic oxygenation (Procedure)
Control group
The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.
干预措施: Usual Care (Procedure)
结局指标
主要结局
Incidence of severe hypoxemia
时间窗: from the start of laryngoscopy to 5 minutes after successful intubation
The incidence of severe hypoxemia defined as the occurrence of at least one episode of oxygen saturation measured by pulse oximetry (SpO2) \< 80%
次要结局
- Incidence of prolonged severe hypoxemia(from the start of laryngoscopy to 5 minutes after successful intubation)
- The highest and lowest SpO2 values during the procedure(from the start of laryngoscopy to 5 minutes after successful intubation)
- The occurrence of each immediate severe complications(from the start of laryngoscopy to 5 minutes after successful intubation)
- The occurrence of each other adverse events(from the start of laryngoscopy to 5 minutes after successful intubation; At Day 28)
- Day-28 mortality(at Day 28)
- Duration of laryngoscopy(From the 1st attempt to the successful intubation)
- Number of laryngoscopies(from the 1st attempt to the successful intubation)