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
  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 3

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

Resource links provided by NLM:


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
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Propofol
Sedation in TCI with propofol
Placebo Comparator: 2 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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux cedex, France, 33076
Centre hospitalier Libourne
Libourne, France, 33505
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:
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00741949     History of Changes
Other Study ID Numbers: CHUBX 2007/29
Study First Received: August 25, 2008
Last Updated: August 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Respiratory failure
Target Controlled Infusion
TCI
Propofol
Noninvasive ventilation
Broncho-alveolar lavage

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 22, 2014