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

September 10, 2017 updated by: Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75 018
        • Hôpital Bichat - Claude Bernard
    • Doubs
      • Besancon, Doubs, France, 25030
        • Hôpital Universitaire Jean Minjoz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of agreement between radiographs, CT scan and lung ultrasonography
Time Frame: 8 days
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.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Study Director: Lila Bouadma, MD,PhD, Hôpital universitaire Bichat- Claude Bernard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 10, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHBesançon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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