Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF (SEDA-FIBRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00741949
First received: August 25, 2008
Last updated: August 25, 2011
Last verified: August 2011

August 25, 2008
August 25, 2011
September 2008
June 2011   (final data collection date for primary outcome measure)
Means of oxygen saturation [ Time Frame: along procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00741949 on ClinicalTrials.gov Archive Site
  • Patient satisfaction [ Time Frame: after procedure ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: After procedure ] [ Designated as safety issue: No ]
  • Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB [ Time Frame: During procedure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF
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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Respiratory Insufficiency
  • Drug: Propofol
    Sedation in TCI with propofol
  • Drug: Placebo
    Isotonic saline solution infusion
  • Experimental: 1
    Intervention: Drug: Propofol
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00741949
CHUBX 2007/29
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Benjamin CLOUZEAU, Dr University Hospital, Bordeaux
Study Chair: Antoine BENARD, Dr University Hospital, Bordeaux
University Hospital, Bordeaux
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP