Broncho-Alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00741949

Purpose

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.

Condition	Intervention	Phase
Respiratory Insufficiency	Drug: Propofol Drug: Placebo	Phase III

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Means of oxygen saturation [ Time Frame: along procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	46
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Propofol Sedation in TCI with propofol
2: Placebo Comparator	Drug: Placebo Isotonic saline solution infusion

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Immunocompetent and immunosuppressed patient
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741949

Contacts

Contact: Benjamin CLOUZEAU, Dr

(33)5 56 79 56 79

benjamin.clouzeau@chu-bordeaux.fr

Locations

France
University Hospital Bordeaux, Groupe Hospitalier Pellegrin	Recruiting
Bordeaux cedex, France, 33076
Contact: Benjamin CLOUZEAU, Dr (33)5 56 79 56 79 benjamtin.clouzeau@chu-bordeaux.fr
Contact: Hoang-Nam BUI, Dr (33)5 56 79 56 79 hoang-nam.bui@chu-bordeaux.fr
Principal Investigator: François Xavier MAHON, MD

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:	Benjamin CLOUZEAU, Dr	University Hospital, Bordeaux
Study Chair:	Antoine BENARD, Dr	University Hospital, Bordeaux

More Information

Publications:

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. Epub 2006 Nov 14.

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.

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	CHUBX 2007/29
Study First Received:	August 25, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00741949
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Respiratory failure
Target Controlled Infusion
TCI

Propofol
Noninvasive ventilation
Broncho-alveolar lavage

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009