Diagnostic Value of Pulmonary Ultrasound in the Diagnosis of Ventilator-associated Pneumoniae (PAVM)

August 27, 2015 updated by: Groupe Hospitalier Paris Saint Joseph
This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Diagnosis and monitoring iconographic lung infection is essentially limited to chest radiography. But this one to bed is a source of information generally unreliable routine.

Lung ultrasound is now an additional technique for confirmation of diagnosis and followed by community acquired pneumonia and monitoring of ventilator-associated pneumonia. The specific pathophysiology of VAP makes particularly efficient lung ultrasound in the diagnosis and monitoring of these attacks. The patient mechanically ventilated, the colonization of the airways is responsible for a continuous seeding of the tracheobronchial tree. As the lesions are scattered throughout the lung parenchyma and are centered on a bronchiole; although there is a predominance of households in the areas most dependent lung. VAP is therefore characterized by inflammatory tissue expansion to the periphery, predominant at the lower lobes and partnering with a ventilation loss varies with the severity of the pneumonia.

Thus, it can be found at an early stage some cells infected around a bronchiole in contact with infected acini normally ventilated. At an advanced stage, this extension to the whole parenchyma results in the widespread presence of small outbreaks in pleural. They are easily and specifically detected by ultrasound in the form of vertical artifacts irregular spacing (irregular Lines B) or small pictures (<0.5 cm) rounded HYPOECHOIC (jucta pleural consolidation) for reliable diagnosis of VAP. The success of an antibiotic is detected by the disappearance of B lines and pleural jucta consolidations. The failure of antibiotic therapy by the appearance of new jucta pleural consolidations which may merge giving lobar consolidation. Community-acquired pneumonia is characterized by the spread of infection in a home adjacent pulmonary segments by providing a systematized typical lobar reached. The diagnosis and monitoring of community-acquired pneumonia is mainly based on monitoring the number and size of household lobar consolidation which is not sufficient for pneumonia Ventilator. This latest study shows that the intensity ultrasound signs is proportional to the extension of outbreaks (lobar consolidations homes and mini homes jucta pleural consolidation). Moreover unlike biological biomarkers such as procalcitonin, it does not reflect the intensity of inflammation.

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following criteria : fever ≥38.5 ° C or <36, 5 ° C, leukocytosis> 10 * 103 / ml or leukopenia <4 * 103 / ml; secretions purulent tracheal; reduction in PaO2 / (FiO2) <300 or PaO2 <60 mmHg)

Description

Inclusion Criteria:

  • Patients in mechanical ventilation for at least 48 hours
  • and new or extension of a radiological image

with at least two of the following clinical criteria:

  • Body temperature ≥ 38.5 ° C or <36 ° C
  • Leukocytes> 10 * 103 / ml or <4 * 103 / ml or> 10% immature cells (in the absence of other known causes).
  • hypoxemia with PaO 2 <60 mmHg or a P / F <300
  • secretions purulent tracheal

Exclusion Criteria:

  • Patient with known pneumonia
  • Patient under 18 years
  • Mechanical ventilation <48h
  • contraindication of pulmonary endoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with suspected VAP

All patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following:criteria :

fever ≥38.5 ° C or <36, 5 ° C leukocytosis> 10 * 103 / ml or leukopenia <4 * 103 / ml secretions purulent tracheal reduction in PaO2 / FiO2 <300 or PaO 2 <60 mmHg

all patients with suspected VAP : biochemestry microbiology lung ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity, specificity and diagnostic accuracy of lung ultrasound (in pleural consolidation homes and irregular lines B, basal consolidation) only and associated with the CPIS (clinical pulmonary infection score)
Time Frame: 48h after mecanic ventilation
48h after mecanic ventilation

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of specific sonographic signs (irregular B lines, pleural consolidation in household) during the VAP
Time Frame: 48h after mecanic ventilation
48h after mecanic ventilation
Diagnostic approach integrating CPIS (Clinical Pulmonary Infection Score), tracheal aspiration and lung ultrasound (LUS - Lung Ultrasound) for the early diagnosis of VAP
Time Frame: 48h after mecanic ventilation
48h after mecanic ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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