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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
  Purpose

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 Intervention
Bacterial Pneumonia
Device: catheter for mini bronchoalveolar lavage

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The primary outcome measure is the rate of positive microbiological culture [ Time Frame: one year ] [ Designated as safety issue: No ]

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 [ 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 ]

Enrollment: 36
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763620

Locations
France
Dr Pascal MEYER
Corbeil, Ile de France, France, 91000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
PLASTIMED Laboratory
Investigators
Principal Investigator: Pascal MEYER, MD Centre Hospitalier Sud Francilien - Corbeil Essonnes
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00763620     History of Changes
Other Study ID Numbers: P080502
Study First Received: September 30, 2008
Last Updated: September 22, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Community acquired pneumonia
Nosocomial pneumonia
Mini bronchoalveolar lavage
Endotracheal aspirates
Expectorated sputum

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 24, 2014