Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF

Respiratory Insufficiency Clinical Trial

— SEDA-FIBRO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741949
• Other study ID #: CHUBX 2007/29
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2008
• Last updated: August 25, 2011
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Drug:
• Propofol
Sedation in TCI with propofol
• Placebo
Isotonic saline solution infusion

Locations

Country	Name	City	State
France	University Hospital Bordeaux, Groupe Hospitalier Pellegrin	Bordeaux cedex
France	Centre hospitalier Libourne	Libourne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Means of oxygen saturation		along procedure	No
Secondary	Patient satisfaction		after procedure	No
Secondary	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		After procedure	No
Secondary	Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB		During procedure	Yes