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NCT Number: NCT00763620

Assessment of the Diagnostic Capacity of the Mini-broncho Alveolar Lavage Performed Through a Suction Catheter

The aim of this study is to develop a safe and effective technique to take sample for lower respiratory tract cultures easy to perform in conditions of acute respiratory failure and spontaneous ventilation for patients admitted in intensive care unit for acute infectious pneumonia and non intubated. The investigators perform sample collection with a mini bronchoalveolar lavage catheter introduced by nasotracheal way through a suction catheter. The purpose of the study is to assess the microbiological diagnostic capacity of this new technique.

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Key information

About this study

At the moment we lack an effective and safe technique to obtain lower respiratory tract cultures for patient with mild serious infectious pneumonia admitted in intensive care unit and non intubated. Invasive procedure may worsen respiratory distress and non invasive procedure such expectorated sputum culture is not enough effective. The purpose of the study is to assess the microbiological diagnosis capacity of a new technique for taking samples from the lower respiratory tract: mini bronchoalveolar lavage performed by naso tracheal way through a suction catheter.Each consecutive patient admitted in intensive care unit for a community acquired or nosocomial pneumonia and not requiring intubation and mechanical ventilation will be included. Written informed consent by patient himself will be required. For each patient, after the introduction of a suction catheter, an endotracheal aspiration will be performed. Then, the mini bronchoalveolar lavage will be performed through the suction catheter with a specific catheter.The whole time of the procedure is about ten minutes.Expectorated sputum will also be ordered for each patient.This study is a pilot and prospective study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age over 18
  • Radiological diagnosis of pneumonia (community acquired or nosocomial)
  • No microbiological diagnosis known
  • Indication for culture of lower respiratory tract
  • Admission in intensive care unit required

Exclusion criteria

  • Age lower than 18
  • Bronchospasm
  • Coagulopathy ( Platelets count below 100 000/mm3, prothrombin time less than 50%, activated partial thromboplastin time ratio higher than 2)
  • Intubation with mechanical ventilation
  • Known microbiological diagnosis
  • Incapacity for consenting himself to the study

Treatment and study plan

catheter for mini bronchoalveolar lavage

Device

For each patient included an endotracheal aspiration and a mini bronchoalveolar lavage will be performed. After local anaesthesia, a suction catheter will be introduced in trachea by nasotracheal way. An endotracheal aspirate will be performed. Then, the mini bronchoalveolar lavage will be performed with the specific catheter introduced through the suction catheter. Expectorated sputum will also be ordered. This procedure will be performed once at the admission patient in intensive care unit.

Primary outcomes

  1. The primary outcome measure is the rate of positive microbiological culture

    Time frame: one year

Secondary outcomes

  1. Comparison between rate of positive culture obtain with mini bronchoalveolar lavage and the two others techniques used in the sudy: endotracheal aspiration and expectorated sputum

    Time frame: one year

  2. Feasibility of the procedure

    Time frame: ten minutes

  3. The acceptance of the procedure

    Time frame: ten minutes

  4. Physiological variables: heart and respiratory rate, oxygen saturation, blood pressure

    Time frame: before procedure and fifteen minutes after procedure

  5. If applicable: complications of the procedure

    Time frame: one day

  6. Time to obtain the result of the culture one day

    Time frame: one day

  7. Time of the procedure

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • PLASTIMED Laboratory

Registry information

Official study title

Assessment of the Diagnostic Capacity of a New Sampling Technique for Lower Respiratory Tract Culture for Patients With Acute Infectious Pneumonia Admitted in Intensive Care Unit and Non Intubated.

Acronym: Mini-LBA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2008
Registry last updated
Sep 23, 2011

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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