NCT00763620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 23, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

September 30, 2008

Last Update Submit

September 22, 2011

Conditions

Bacterial Pneumonia

Keywords

Community acquired pneumoniaNosocomial pneumoniaMini bronchoalveolar lavageEndotracheal aspiratesExpectorated sputum

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the rate of positive microbiological culture

    one year

Secondary Outcomes (7)

  • 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

    one year

  • Feasibility of the procedure

    ten minutes

  • The acceptance of the procedure

    ten minutes

  • Physiological variables: heart and respiratory rate, oxygen saturation, blood pressure

    before procedure and fifteen minutes after procedure

  • If applicable: complications of the procedure

    one day

  • +2 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Catheter for mini bronchoalveolar lavage

Device: catheter for mini bronchoalveolar lavage

Interventions

catheter for mini bronchoalveolar lavageDEVICE

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Pascal MEYER

Corbeil-Essonnes, Île-de-France Region, 91000, France

Location

Related Publications (1)

  • 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.

    PMID: 23882105DERIVED

MeSH Terms

Conditions

Pneumonia, BacterialCommunity-Acquired PneumoniaHealthcare-Associated Pneumonia

Interventions

Catheters

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesCommunity-Acquired InfectionsCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Pascal MEYER, MD

    Centre Hospitalier Sud Francilien - Corbeil Essonnes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

February 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 23, 2011

Record last verified: 2011-06

Locations

FR(1)