Fiberoptic Bronchoscopy With Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol Target Controled Infusion in Patient With Acute Hypoxemic Respiratory Failure. A Randomized Controlled Study : SEDA-FIBRO.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Means of oxygen saturation
研究概览
简要总结
Fiberoptic bronchoscopy (FOB) is an important tool for the diagnosis of pulmonary diseases, more particularly in infectious pneumonia. In patients with severe acute hypoxemic respiratory failure, FOB may be contra-indicated until the patient is intubated and control of its oxygenation obtained. In the literature several authors showed that performing FOB under non invasive ventilation (NIV) preserved oxygenation of the patient; and the recent French Consensus on NIV recommends performing FOB under NIV in patients with acute hypoxemic respiratory failure.
Nevertheless this procedure remains uncomfortable in most patients with respiratory failure. In addition, patient's agitation may lead to desaturation, and compromise the realization of FOB.
详细描述
In acute hypoxemic respiratory failure, FOB with BAL can be life threatening because of a deep oxygen desaturation. Performing FOB under NIV has been shown efficient to prevent episodes of desaturation. Several modes of ventilation have been tried ; Continuous Positive Airways Pressure and Pressure Support Ventilation both showed superiority when compared to oxygen supplementation alone. The recent French consensus on NIV recommends performing FOB under NIV in hypoxemic conditions.
Efficacy of NIV can be altered by patient agitation or asynchronism with the ventilator. Though, some authors have proposed the use of sedative agents like remifentanyl during NIV.
To our knowledge, none study has evaluated the beneficial effect of sedation during a FOB with BAL under NIV.
Propofol is an anesthetic agent which can be administered in TCI, to maintain a constant concentration in the target cerebral compartment. Propofol is widely used in different types of anesthesia. Using the same concept, authors have reported its use in sedation, with smaller target concentrations. TCI sedation with propofol preserves patient's spontaneous ventilation, and does not alter hemodynamic parameters.
Our hypothesis is that sédation by TCI with propofol will lead to best oxygen saturation than without this intervention in patients with acute hypoxemic respiratory failure and undergoing FOB with BAL under NIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute respiratory failure defined by clinical signs of respiratory failure (polypnea, use of accessory respiratory muscle) and a PaO2/FiO2 ratio < 250
- •Need for a diagnosis FOB with BAL
- •Informed consent signed
排除标准
- •Contraindication of NIV
- •FOB with bronchial biopsies
- •Acute coronary syndrome
- •Thrombopenia < 30.000 / mm3 despite platelets transfusion
- •Coagulation disorders
- •PaO2/FiO2 ratio < 80 under NIV
- •Persistent respiratory acidosis under NIV (pH < 7,32)
- •Propofol allergy
- •Xylocaïne allergy
- •Pregnancy
- •Age < 18 years or > 90 years
- •Weight > 150 kg or < 30 kg
- •Inclusion in another clinical protocol
研究组 & 干预措施
1
干预措施: Propofol (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Means of oxygen saturation
时间窗: along procedure
次要结局
- Patient satisfaction(after procedure)
- Facilitation of the procedure for the fibroscopist: Length of the procedure Volume of BAL aspiration in percentage of aliquot injection Quality of the BAL on cytologic examination(After procedure)
- Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB(During procedure)
