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CT Scan and Lung Ultrasonography to Improve Diagnostic of Ventilation Acquired Pneumonia in ICU (ECTOPICUS)

This study is not yet open for participant recruitment.
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Verified January 2017 by Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT03018431
First received: January 10, 2017
Last updated: January 11, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention
Ventilator-Associated Pneumonia Tracheobronchitis Other: CT Scan

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Days
Official Title: Impact of CT Scan and Lung Ultrasonogrpahy in Early Diagnostic Accuracy for Ventilation Acquired Lower Respiratory Tract Infections in Intensive Care Units.

Resource links provided by NLM:


Further study details as provided by Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • Concordance of diagnostic of tracheo-bronchitis or pneumonia under mechanical ventilation, between physician in charge and independent observator cunducting ultrasound and CT scan evaluation. [ Time Frame: 8 days ]

Secondary Outcome Measures:
  • rate of agreement between radiographs, CT scan and lung ultrasonography [ Time Frame: 8 days ]
  • correlation between evolution according to management of infection and misdiagnostic of pneumonia or tracheo-bronchitis or not by the clinician. [ Time Frame: 8 days ]

    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.



Estimated Enrollment: 160
Study Start Date: January 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
Other: CT Scan
patients undergoing chest CT scan at admission and repeated lung ultrasonography
Other Name: Ultrasonography

Detailed Description:

Diagnostic of VAP and tracheobronchitis is often difficult in UC under mechanical ventilation, and usually occuring quite early after initial phase of hemodynamic instability, and characterized by needs of massive fluids supports and drugs infusion. The goldstandard is still standard chest X-ray, providing a picture of the whole abnormalities due to cardiac failure, and cardiogenic pulmonary edema. The high rate of water in chest of the patients under ventilation assistance and hemodynamic support is responsible of a misinterpretation of the abnormalities visualized on the radiographs. It is often considered that Lung ultrasonography is useful to appreciate the involvement of pleural effusion, explaning etiologies of hypoxemia, where cardiac failure is excluded by the simultaneous ultrasonographic evaluation. However, it is not well recognized that pulmonary parenchyma can be explored through echography, and that it provides a lot of information about the amount of liquid inside it, and the default of aeration. Thus, it can in real time help the physician to guide the therapeutics and manage the ventilation better. Moreover, the suspicion of infection, clinically and biologically leads to the early prescription of antibiotics, given that the radiography is abnormal. Knowing that there is now parenchymal consolidation but rather effusion or a certain degree of pulmonary edema could help avoiding treating falsely a respiratory infection.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Every patient place under mechanical ventilation at least for 48 hours, suspected of lower respiratory tract infection, based on CDC criterias of ventilatior-acquired pneumonia.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03018431

Contacts
Contact: Paul-Henri WICKY, MD 003680129209 phwicky@outlook.fr

Locations
France
Hôpital Universitaire Jean Minjoz Not yet recruiting
Besancon, Doubs, France, 25030
Contact: Paul-Henri WICKY    003680129209    phwicky@outook.fr   
Hôpital Bichat - Claude Bernard Active, not recruiting
Paris, France, 75 018
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Study Director: Lila Bouadma, MD,PhD Hôpital universitaire Bichat- Claude Bernard
  More Information

Publications:

Responsible Party: Paul-Henri WICKY, Medicla Doctor, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03018431     History of Changes
Other Study ID Numbers: CHBesançon
Study First Received: January 10, 2017
Last Updated: January 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon:
Lung ultrasonography
Chest CT scan
ventilator-associated pneumonia
ventilator-associated tracheobronchitis
antibiotic stewardship

Additional relevant MeSH terms:
Pneumonia
Respiratory Tract Infections
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Infection
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on August 18, 2017