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NCT Number: NCT00741949

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Bordeaux, Groupe Hospitalier Pellegrin, Bordeaux, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Sedation in TCI with propofol

Placebo

Drug

Isotonic saline solution infusion

Primary outcomes

  1. Means of oxygen saturation

    Time frame: along procedure

Secondary outcomes

  1. Patient satisfaction

    Time frame: after procedure

  2. 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

  3. Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB

    Time frame: During procedure

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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.

Acronym: SEDA-FIBRO

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2008
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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