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

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ClinicalTrials.gov Identifier: NCT02536547
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Collaborator:
Istituto Nazionale di Ricovero e Cura per Anziani
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:
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).

Condition or disease Intervention/treatment
Ventilator-associated Pneumonia Sepsis Device: VAP

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Value of Pulmonary Ultrasound in the Diagnosis of Ventilator-associated Pneumoniae
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Ultrasound

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

Device: VAP
all patients with suspected VAP : biochemestry microbiology lung ultrasound




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Frequency of specific sonographic signs (irregular B lines, pleural consolidation in household) during the VAP [ Time Frame: 48h after mecanic ventilation ]
  2. 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 ]

Biospecimen Retention:   None Retained

biochemistry : procalcitonin, leukocytes, neutrophils

microbiology : bronchoalveolar lavage and tracheal aspiration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536547


Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Istituto Nazionale di Ricovero e Cura per Anziani
Investigators
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Principal Investigator: Bélaïd BOUHEMAD, Dr Groupe Hospitalier Paris Saint Joseph
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02536547    
Other Study ID Numbers: 2013-A01818-37
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Clinical pulmonary infection score
sepsis
lung ultrasound
ventilator-associated pneumonia
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Cross Infection