Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia

NCT02244723 | Completed

• 1 other identifier: VPLUS
• Study Type: observational
• Target: 98
• Locations: 2 countries
• Sites: 2

Brief Summary

Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly improves outcomes, making rapid identification of patients with VAP an important clinical goal. This application is for support of a prospective, multi-centered study to evaluate the diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could allow for early and reliable diagnosis of bacterial VAP. Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung ultrasound alone and in association with the CPIS. Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural consolidation, irregular B-lines) in VAP. Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung ultrasound, and unprotected tracheal aspirate (UTA).

Conditions

Ventilator-Associated Pneumonia

Keywords

Ventilator-Associated Pneumonia; diagnosis

Outcome Measures

Primary Outcomes (1)

• ventilator-associated pneumonia.

  Ventilator associated pneumonia is diagnosed when patient has a positive broncho alveolar lavage (positive cultiure \>10\*3 CFU/ml) and clinical criteria (◦Body temperature ≥ 38.5° C (101° F) or \< 36° C (97° F) * White blood cell count \> 10,000/ml or \< 4,000/ml or \> 10% immature cells * Partial pressure of oxygen in arterial blood \< 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio \< 300 * Purulent respiratory secretion)

  up to 30days

Secondary Outcomes (5)

• Duration of stay in ICU

  up to 60 days

• Duration of hospital say

  up to 60 days

• Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose ventilator-associated pneumonia

  up to 30 days

• sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with the CPIS to diagnose ventilator-associated pneumonia

  up to 30 days

• sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with unprotected tracheal aspirate to diagnose ventilator-associated pneumonia

  up to 30 days

Study Arms (1)

Patients with suspected VAP

Only one group is studied : mechanically-ventilated patients with suspected VAP in ICUs. For each patient a lung ultrasound examination will be performed.

Other: Lung ultrasound examination

Interventions

Lung ultrasound examination OTHER

Lung ultrasound (LUS) is increasingly being used at the bedside for assessing alveolar-interstitial syndrome, lung consolidation, pneumonia, pneumothorax, and pleural effusion. It could be an easily repeatable noninvasive tool for diagnosis of ventilator associated pneumonia

Patients with suspected VAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects will be recruited from mechanically-ventilated patients with suspected VAP in ICUs

You may qualify if:

• Mechanical ventilation for at least 48 hours,
• New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and
• A minimum of two of the following clinical criteria:
• Body temperature ≥ 38.5° C (101° F) or \< 36° C (97° F)
• White blood cell count \> 10,000/ml or \< 4,000/ml or \> 10% immature cells
• Partial pressure of oxygen in arterial blood \< 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio \< 300
• Purulent respiratory secretions

You may not qualify if:

• Known ongoing pneumonia
• Patient younger than 18 years old
• Mechanical ventilation \<48 hours
• Contraindication to bronchoscopy

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

GH Paris Saint Joseph

Paris, 75014, France

Location

Rianimazione I, (Dipartement of Anesthesia and Intensive Care Unit) of Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Related Publications (4)

• Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.

  PMID: 19633538 BACKGROUND

• Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.

  PMID: 20851923 BACKGROUND

• Wang G, Ji X, Xu Y, Xiang X. Lung ultrasound: a promising tool to monitor ventilator-associated pneumonia in critically ill patients. Crit Care. 2016 Oct 27;20(1):320. doi: 10.1186/s13054-016-1487-y.

  PMID: 27784331 DERIVED

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Biochemical data (WBC count with differential, arterial blood gas) * Microbiological data (UTA and BAL) - UTA data must have been collected within 24 hours of enrollment and BAL data within 12 hours of enrollment (unprotected tracheal aspirate (UTA)- fibrobronchoscopy with protected distal sampling)

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Disease

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 19, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

IT (1); FR (1)