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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00763620
Acronym
Mini-LBA
Enrollment
36
Registered
2008-10-01
Start date
2009-02-28
Completion date
2011-06-30
Last updated
2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Pneumonia

Keywords

Community acquired pneumonia, Nosocomial pneumonia, Mini bronchoalveolar lavage, Endotracheal aspirates, Expectorated sputum

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.

Interventions

DEVICEcatheter 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.

Sponsors

PLASTIMED Laboratory
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the rate of positive microbiological cultureone year

Secondary

MeasureTime frame
Feasibility of the procedureten minutes
The acceptance of the procedureten minutes
Physiological variables: heart and respiratory rate, oxygen saturation, blood pressurebefore procedure and fifteen minutes after procedure
Comparison between rate of positive culture obtain with mini bronchoalveolar lavage and the two others techniques used in the sudy: endotracheal aspiration and expectorated sputumone year
Time to obtain the result of the culture one dayone day
Time of the procedureone day
If applicable: complications of the procedureone day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026