Respiratory Insufficiency Clinical Trial
Official title:
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.
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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