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

NCT03018431 | Unknown

• 1 other identifier: CHBesançon
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ventilator-Associated Pneumonia; Tracheobronchitis

Keywords

Lung ultrasonography; Chest CT scan; ventilator-associated pneumonia; ventilator-associated tracheobronchitis; antibiotic stewardship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• rate of agreement between radiographs, CT scan and lung ultrasonography

  8 days

• correlation between evolution according to management of infection and misdiagnostic of pneumonia or tracheo-bronchitis or not by the clinician.

  8 days

Study Arms (2)

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

Interventions

CT Scan OTHER

patients undergoing chest CT scan at admission and repeated lung ultrasonography

Also known as: Ultrasonography

independent evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (2)

Hôpital Universitaire Jean Minjoz

Besançon, Doubs, 25030, France

Location

Hôpital Bichat - Claude Bernard

Paris, 75 018, France

Location

Related Publications (4)

• 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.

  PMID: 27324241 RESULT

• 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.

  PMID: 26836896 RESULT

• 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.

  PMID: 26472037 RESULT

• 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.

  PMID: 26168322 RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Lila Bouadma, MD,PhD

  Hôpital universitaire Bichat- Claude Bernard

  STUDY DIRECTOR

Central Study Contacts

Paul-Henri WICKY, MD

CONTACT

003680129209; phwicky@outlook.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicla Doctor

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: October 15, 2017
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2019
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)