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

NCT ID: NCT00763620

Last Updated: 2011-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-06-30

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.

Conditions

Bacterial Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Catheter for mini bronchoalveolar lavage

Group Type: EXPERIMENTAL

catheter for mini bronchoalveolar lavage

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PLASTIMED Laboratory

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal MEYER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien - Corbeil Essonnes

Locations

Dr Pascal MEYER

Corbeil-Essonnes, Île-de-France Region, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23882105 (View on PubMed)

Other Identifiers

P080502

Identifier Type: -

Identifier Source: org_study_id