Clinical trial NCT00763620: Assessment of the Diagnostic Capacity of the Mini-broncho Alveolar Lavage Performed Through a Suction Catheter
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
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Pneumonia
Keywords: Community acquired pneumonia
Nosocomial pneumonia
Mini bronchoalveolar lavage
Endotracheal aspirates
Expectorated sputum
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: PLASTIMED Laboratory
First posted: 2008-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The primary outcome measure is the rate of positive microbiological culture
timeFrame: one year
Secondary outcomes:
measure: 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
timeFrame: one year
measure: Feasibility of the procedure
timeFrame: ten minutes
measure: The acceptance of the procedure
timeFrame: ten minutes
measure: Physiological variables: heart and respiratory rate, oxygen saturation, blood pressure
timeFrame: before procedure and fifteen minutes after procedure
measure: If applicable: complications of the procedure
timeFrame: one day
measure: Time to obtain the result of the culture one day
timeFrame: one day
measure: Time of the procedure
timeFrame: one day
Other outcomes:
Locations:
city: Corbeil
country: France
facility: Dr Pascal MEYER
state: Ile de France
Study officials:
affiliation: Centre Hospitalier Sud Francilien - Corbeil Essonnes
name: Pascal MEYER, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.