Ventilator-Associated Pneumonia Clinical Trial
— ECTOPICUSOfficial title:
Impact of CT Scan and Lung Ultrasonogrpahy in Early Diagnostic Accuracy for Ventilation Acquired Lower Respiratory Tract Infections in Intensive Care Units.
We aim to show that systematic ultrasonography performed in ventilated patients suspected of
ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and
helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is
considered.
Chest CT scan is often performed before or just after admission in ICU, and usually show
abnormalities that are revealed later on standard radiographs.
This last exam is traditionally considered as the gold standard to prove new pulmonary
infiltrates, but the correlation with parenchymal consolidation is pretty low, and lead to
over-diagnosing pneumonia, thus leading to a massive and maybe sometimes unconsidered
prescription of antibiotic therapy.
Lung ultrasonography conducted systematically within the 3 first days after suspcion of
pneumonia could help making the difference between real infection-linked lesions, and banal
abnormalities following the hydric inflation of intra-thoracic organs, for instance pulmonary
edema or pleural effusion.
An independent evaluation using lung ultrasound, and analysis of CT scan acquisition when
performed, compared with the physician in charge of the patient appreciation by suggesting
him to provide his own probability of pneumonia upon routine clinical and biological datas.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | June 2019 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Immunocompetent subject, - fever and/or purulent tracheal secretions and/or hyperleukocytosis or leukopenia, associated with a positive microbiological sample (within broncho-alveolar leakage, endotracheal aspiration, or distal sample), - invasive mechanical ventilation initiated since at least 48hours, and suppose to be maintained for at least 48hours Exclusion Criteria: - Immunocompromised-patients defined by ; HIV treated or not, patient under corticotherapy, immunotherapy, inflammatory systemic diseases, solid organ transplant, solid tumor treated or not, bone marrow transplant or stem cells graft, hematological malignancy known or under treatment, - moribond, - ventilation expected to last less than 48hours, - minor-aged patients, - no social insurance or isolation, - mental disability making the understanding of the purpose of too difficult. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Universitaire Jean Minjoz | Besancon | Doubs |
France | Hôpital Bichat - Claude Bernard | Paris |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acqu — View Citation
Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR’Echo Col — View Citation
Martin-Loeches I, Povoa P, Rodríguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study. Inci — View Citation
Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance of diagnostic of tracheo-bronchitis or pneumonia under mechanical ventilation, between physician in charge and independent observator cunducting ultrasound and CT scan evaluation. | 8 days | ||
Secondary | rate of agreement between radiographs, CT scan and lung ultrasonography | 8 days | ||
Secondary | correlation between evolution according to management of infection and misdiagnostic of pneumonia or tracheo-bronchitis or not by the clinician. | improving under treatment or worsening without antibiotic therapy when pneumonia diagnostic is valid or not, making further considering the management of antibiotic therapy by the physician guided by CT scan and/or ultrasonography. quantifying amount of situations when diagnostic of pneumonia is validated retrospectively by the adjudication, and delayed starting of antibiotics when diagnostic is not patent early in the standard evaluation, thus conducting to an increased risk of morbi-mortality. |
8 days |
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