CT Scan and Lung Ultrasonography to Improve Diagnostic of Ventilation Acquired Pneumonia in ICU
NCT ID: NCT03018431
Last Updated: 2017-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
160 participants
OBSERVATIONAL
2017-10-15
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Quantitative Computed Tomography for Mortality Risk Stratification in ARDS
NCT06113276
Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome
NCT04603755
Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP
NCT03917888
Lung Response to a Higher PEEP During Severe Pneumonia: a CT Study
NCT07112976
Application of Indicator Based-electrical Impedance Tomography Method Assess Lung Regional Perfusion in ICU Patients
NCT04081142
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The same thoughts can be held concerning Chest CT Scan, an exam often realized at the early stage of management in a critical situation. We can take for granted that when occurring in the 48 first hours of resuscitation, this exam shows in a certain number of cases preexisting abnormalities, that are revealed severla hours later by Chest radiograph, when the suspicion of respiratory infection acquired under ventilation emerge. If we take into account that these abnormalities seen on radiographs are just correlated to those that could be seen on CT, but with a certain delay, and are not de novo, it could lead to an overestimating of ventilation acquired pneumonia, because the criteria of a new radiographic infiltrate won't be valid anymore. The diagnostic of tracheobronchitis could then be more appropriated in a certain number of situations.
Our aim is to verify retrospectively by an adjudication committee, that this early CT Scan, within the 2 first days after admission if patient is ventilated and/or suspicion of lower respiratory tract infection, and a systematic lung ultrasonographic evaluation, provided by an independent operator, could change our appreciation of the frequency of ventilation-acquired pneumonia, comparing to the appreciation of th physician in charge of the patients.
We are thus conducting a repeated evaluation, at day 0, day 3 and day 7 with ultrasonography, in order to give a probability of pneumonia or tracheobronchitis by the echographist operator, and suggesting the physician to give his own probability based on clinical and biological routine datas. We then measure the rate of agreement between the two parts, to see how far the systematic evaluation using pleural ultrasonography could help defining the probability of infection, and validating the diagnostic of pneumonia. The impact should be to improve the accuracy within the first days 2 or 3 days after suspicion, when repeated, if possible by the same operator. One of the main benefit could be the reduction or better reevaluation of antibiotic therapy, if diagnostic of pneumonia is rejected secondary, eventually shorter course of treatment could be chosen, even if this point deserve to be evaluated in further studies.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Physician routine evaluation
systematic evaluation of the probability of tracheobronchitis or pneumonia based upon clinical and biological, associated with standard radiographs, performed by the physician in chrage of the patient.
No interventions assigned to this group
independent evaluation
systematic evaluation of the probability of tracheobronchitis or pneumonia based upon early CT scan, and repeated lung ultrasonography, performed by an independent operator.
CT Scan
patients undergoing chest CT scan at admission and repeated lung ultrasonography
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CT Scan
patients undergoing chest CT scan at admission and repeated lung ultrasonography
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paul-Henri WICKY
Medicla Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lila Bouadma, MD,PhD
Role: STUDY_DIRECTOR
Hôpital universitaire Bichat- Claude Bernard
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Universitaire Jean Minjoz
Besançon, Doubs, France
Hôpital Bichat - Claude Bernard
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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 Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
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.
Martin-Loeches I, Povoa P, Rodriguez 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. Incidence and prognosis of ventilator-associated tracheobronchitis (TAVeM): a multicentre, prospective, observational study. Lancet Respir Med. 2015 Nov;3(11):859-68. doi: 10.1016/S2213-2600(15)00326-4. Epub 2015 Oct 22.
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-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHBesançon
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.