- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02536547
Diagnostic Value of Pulmonary Ultrasound in the Diagnosis of Ventilator-associated Pneumoniae (PAVM)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A01818-37
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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