Diagnostic Value of Pulmonary Ultrasound in the Diagnosis of Ventilator-associated Pneumoniae

NCT02536547 | Completed

• 1 other identifier: 2013-A01818-37
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP).

Conditions

Ventilator-associated Pneumonia; Sepsis

Keywords

Clinical pulmonary infection score; sepsis; lung ultrasound; ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity and diagnostic accuracy of lung ultrasound (in pleural consolidation homes and irregular lines B, basal consolidation) only and associated with the CPIS (clinical pulmonary infection score)

  48h after mecanic ventilation

Secondary Outcomes (2)

• Frequency of specific sonographic signs (irregular B lines, pleural consolidation in household) during the VAP

  48h after mecanic ventilation

• Diagnostic approach integrating CPIS (Clinical Pulmonary Infection Score), tracheal aspiration and lung ultrasound (LUS - Lung Ultrasound) for the early diagnosis of VAP

  48h after mecanic ventilation

Study Arms (1)

patients with suspected VAP

All patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following:criteria : fever ≥38.5 ° C or \<36, 5 ° C leukocytosis\> 10 \* 103 / ml or leukopenia \<4 \* 103 / ml secretions purulent tracheal reduction in PaO2 / FiO2 \<300 or PaO 2 \<60 mmHg

Device: VAP

Interventions

VAP DEVICE

all patients with suspected VAP : biochemestry microbiology lung ultrasound

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

All patients with suspected VAP will be included in the study (new or extension of a radiological image in a patient in mechanical ventilation for at least 48 hours associated with at least two of the following criteria : fever ≥38.5 ° C or \<36, 5 ° C, leukocytosis\> 10 \* 103 / ml or leukopenia \<4 \* 103 / ml; secretions purulent tracheal; reduction in PaO2 / (FiO2) \<300 or PaO2 \<60 mmHg)

You may qualify if:

• Patients in mechanical ventilation for at least 48 hours
• and new or extension of a radiological image
• with at least two of the following clinical criteria:
• Body temperature ≥ 38.5 ° C or \<36 ° C
• Leukocytes\> 10 \* 103 / ml or \<4 \* 103 / ml or\> 10% immature cells (in the absence of other known causes).
• hypoxemia with PaO 2 \<60 mmHg or a P / F \<300
• secretions purulent tracheal

You may not qualify if:

• Patient with known pneumonia
• Patient under 18 years
• Mechanical ventilation \<48h
• contraindication of pulmonary endoscopy

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Istituto Nazionale di Ricovero e Cura per Anziani: collaborator

Biospecimen

Retention: NONE RETAINED

biochemistry : procalcitonin, leukocytes, neutrophils microbiology : bronchoalveolar lavage and tracheal aspiration

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Sepsis

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; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Bélaïd BOUHEMAD, Dr

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 1, 2015
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2015-08