An observational study in Ventilator-Associated Pneumonia, sponsored by Fondation Hôpital Saint-Joseph. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly improves outcomes, making rapid identification of patients with VAP an important clinical goal.
This application is for support of a prospective, multi-centered study to evaluate the diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could allow for early and reliable diagnosis of bacterial VAP.
Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung ultrasound alone and in association with the CPIS.
Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural consolidation, irregular B-lines) in VAP.
Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung ultrasound, and unprotected tracheal aspirate (UTA).
Patients will be enrolled within 24 hours of the point at which criteria are met for suspected VAP. Upon enrollment, the following variables will be recorded from the online medical record, and a Clinical Pulmonary Infection Score will be calculated.
Lung ultrasound will be performed within 24 hours of the point at which criteria are met for suspected VAP. Lung ultrasound will include examination of both lungs. Each hemithorax will be divided into three regions using anterior and posterior axillary lines as landmarks. Each of these regions will be further divided into upper and lower quadrants, yielding a total of 6 quadrants per hemithorax. Examination will specifically identify the presence or absence of the following lung ultrasound findings: normal pleural A lines, non-coalescent B lines, coalescent B lines, consolidations (subpleural or lobar), and linear air bronchograms. A Lung Ultrasound Aeration Score will be calculated based on these findings. Ultrasonographic diagnosis of VAP will be defined based on the presence of subpleural consolidation, entire lobar consolidation, or air bronchogram within consolidation.
The results of microbiological data will be followed up for confirmation of culture results. Cultures will be considered positive if ≥ 100,000 bacterial colony-forming units (cfu) are isolated.
At day #28 of study enrollment, the patient's status will be documented (alive vs. deceased, inpatient vs. discharged).
2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.
This study's enrollment of 98 is below the median of 201 across 689 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
subjects will be recruited from mechanically-ventilated patients with suspected VAP in ICUs
A minimum of two of the following clinical criteria:
Exclusion Criteria:
Known ongoing pneumonia
Only one group is studied : mechanically-ventilated patients with suspected VAP in ICUs. For each patient a lung ultrasound examination will be performed.
Other: Lung ultrasound examination
Lung ultrasound (LUS) is increasingly being used at the bedside for assessing alveolar-interstitial syndrome, lung consolidation, pneumonia, pneumothorax, and pleural effusion. It could be an easily repeatable noninvasive tool for diagnosis of ventilator associated pneumonia
ventilator-associated pneumonia.
Ventilator associated pneumonia is diagnosed when patient has a positive broncho alveolar lavage (positive cultiure \>10\*3 CFU/ml) and clinical criteria (◦Body temperature ≥ 38.5° C (101° F) or \< 36° C (97° F) * White blood cell count \> 10,000/ml or \< 4,000/ml or \> 10% immature cells * Partial pressure of oxygen in arterial blood \< 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio \< 300 * Purulent respiratory secretion)
Time frame: up to 30days
Duration of stay in ICU
Time frame: up to 60 days
Duration of hospital say
Time frame: up to 60 days
Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose ventilator-associated pneumonia
Time frame: up to 30 days
sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with the CPIS to diagnose ventilator-associated pneumonia
Time frame: up to 30 days
sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with unprotected tracheal aspirate to diagnose ventilator-associated pneumonia
Time frame: up to 30 days
Plan to share: Undecided
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph