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

Primary Purpose

Bacterial Pneumonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
catheter for mini bronchoalveolar lavage
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bacterial Pneumonia focused on measuring Community acquired pneumonia, Nosocomial pneumonia, Mini bronchoalveolar lavage, Endotracheal aspirates, Expectorated sputum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr Pascal MEYER

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Catheter for mini bronchoalveolar lavage

Outcomes

Primary Outcome Measures

The primary outcome measure is the rate of positive microbiological culture

Secondary Outcome Measures

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
Feasibility of the procedure
The acceptance of the procedure
Physiological variables: heart and respiratory rate, oxygen saturation, blood pressure
If applicable: complications of the procedure
Time to obtain the result of the culture one day
Time of the procedure

Full Information

First Posted
September 30, 2008
Last Updated
September 22, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
PLASTIMED Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT00763620
Brief Title
Assessment of the Diagnostic Capacity of the Mini-broncho Alveolar Lavage Performed Through a Suction Catheter
Acronym
Mini-LBA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
PLASTIMED Laboratory

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Pneumonia
Keywords
Community acquired pneumonia, Nosocomial pneumonia, Mini bronchoalveolar lavage, Endotracheal aspirates, Expectorated sputum

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Catheter for mini bronchoalveolar lavage
Intervention Type
Device
Intervention Name(s)
catheter for mini bronchoalveolar lavage
Intervention Description
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 Measure Information:
Title
The primary outcome measure is the rate of positive microbiological culture
Time Frame
one year
Secondary Outcome Measure Information:
Title
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
Title
Feasibility of the procedure
Time Frame
ten minutes
Title
The acceptance of the procedure
Time Frame
ten minutes
Title
Physiological variables: heart and respiratory rate, oxygen saturation, blood pressure
Time Frame
before procedure and fifteen minutes after procedure
Title
If applicable: complications of the procedure
Time Frame
one day
Title
Time to obtain the result of the culture one day
Time Frame
one day
Title
Time of the procedure
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal MEYER, MD
Organizational Affiliation
Centre Hospitalier Sud Francilien - Corbeil Essonnes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Pascal MEYER
City
Corbeil
State/Province
Ile de France
ZIP/Postal Code
91000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23882105
Citation
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.
Results Reference
derived

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

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