Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.

      Thus, we designed a randomized controlled study. Eligible patients will be randomized in two
      groups. In the treatment group, patients will receive sedation with propofol during the
      procedure of FOB under NIV. In the other group, patients will receive a placebo during the
      same procedure. Patients and fibroscopist won't be aware of the randomization group
    

Intervention name(s): Propofol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sedation in TCI with propofol; Isotonic saline solution infusion
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Respiratory failure; Target Controlled Infusion; TCI; Propofol; Noninvasive ventilation; Broncho-alveolar lavage