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

This study has been completed.
Sponsor:
Collaborator:
PLASTIMED Laboratory
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00763620
First received: September 30, 2008
Last updated: September 22, 2011
Last verified: June 2011

September 30, 2008
September 22, 2011
February 2009
June 2011   (final data collection date for primary outcome measure)
The primary outcome measure is the rate of positive microbiological culture [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00763620 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Feasibility of the procedure [ Time Frame: ten minutes ] [ Designated as safety issue: No ]
  • The acceptance of the procedure [ Time Frame: ten minutes ] [ Designated as safety issue: Yes ]
  • Physiological variables: heart and respiratory rate, oxygen saturation, blood pressure [ Time Frame: before procedure and fifteen minutes after procedure ] [ Designated as safety issue: Yes ]
  • If applicable: complications of the procedure [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • Time to obtain the result of the culture one day [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Time of the procedure [ Time Frame: one day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of the Diagnostic Capacity of the Mini-broncho Alveolar Lavage Performed Through a Suction Catheter
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.

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Bacterial Pneumonia
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.
Experimental: 1
Catheter for mini bronchoalveolar lavage
Intervention: Device: catheter for mini bronchoalveolar lavage
Meyer P, Rousseau H, Maillet JM, Thierry S, Sy O, Vicaut E, Thiolliere F, Choukroun G, Chergui K, Chevrel G, Maury E. Evaluation of blind nasotracheal suctioning and non-bronchoscopic mini-bronchoalveolar lavage in critically ill patients with infectious pneumonia: a preliminary study. Respir Care. 2014 Mar;59(3):345-52. doi: 10.4187/respcare.02356. Epub 2013 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00763620
P080502
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
PLASTIMED Laboratory
Principal Investigator: Pascal MEYER, MD Centre Hospitalier Sud Francilien - Corbeil Essonnes
Assistance Publique - Hôpitaux de Paris
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP