Clinical trial NCT00741949: Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Insufficiency
Keywords: Respiratory failure
Target Controlled Infusion
TCI
Propofol
Noninvasive ventilation
Broncho-alveolar lavage
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Means of oxygen saturation
timeFrame: along procedure
Secondary outcomes:
measure: Patient satisfaction
timeFrame: after procedure
measure: 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
timeFrame: After procedure
measure: Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB
timeFrame: During procedure
Other outcomes:
Locations:
city: Bordeaux cedex
country: France
facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin
city: Libourne
country: France
facility: Centre hospitalier Libourne
Study officials:
affiliation: University Hospital, Bordeaux
name: Benjamin CLOUZEAU, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, Dr
role: STUDY_CHAIR
References:
citation: Constantin JM, Schneider E, Cayot-Constantin S, Guerin R, Bannier F, Futier E, Bazin JE. Remifentanil-based sedation to treat noninvasive ventilation failure: a preliminary study. Intensive Care Med. 2007 Jan;33(1):82-7. doi: 10.1007/s00134-006-0447-4. Epub 2006 Nov 14.
citation: Nieuwenhuijs D, Sarton E, Teppema LJ, Kruyt E, Olievier I, van Kleef J, Dahan A. Respiratory sites of action of propofol: absence of depression of peripheral chemoreflex loop by low-dose propofol. Anesthesiology. 2001 Oct;95(4):889-95. doi: 10.1097/00000542-200110000-00017.