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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00763620
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : September 23, 2011
PLASTIMED Laboratory
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Device: catheter for mini bronchoalveolar lavage Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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.
Study Start Date : February 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: 1
Catheter for mini bronchoalveolar lavage
Device: catheter for mini bronchoalveolar lavage
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 Outcome Measures :
  1. The primary outcome measure is the rate of positive microbiological culture [ Time Frame: one year ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763620

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Dr Pascal MEYER
Corbeil, Ile de France, France, 91000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
PLASTIMED Laboratory
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Principal Investigator: Pascal MEYER, MD Centre Hospitalier Sud Francilien - Corbeil Essonnes
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00763620    
Other Study ID Numbers: P080502
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: June 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Community acquired pneumonia
Nosocomial pneumonia
Mini bronchoalveolar lavage
Endotracheal aspirates
Expectorated sputum
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections