Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

Study Overview
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Brief Summary
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The study evaluates whether lung ultrasound monitoring could lead to earlier detection of ventilator associated pneumonia and influence outcome. Half of the participants will be diagnosed with VAP using a combination of lung ultrasound and clinical features and half will be diagnosed using the Johanson criteria, which is a combination of clinical features and chest x-ray.

Detailed Description
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The current guidelines recommend the use of chest x-ray or computed tomography of the chest to aid in the diagnosis of VAP. However many studies have shown that chest x-ray is neither very sensitive nor specific for pneumonia, and computed tomography, though has the highest diagnostic accuracy, is not routinely performed due to logistics, safety concerns, economics and radiation exposure. Emerging studies including meta-analyses have shown high sensitivity and specificity of lung ultrasound in diagnosing pneumonia. When combined with clinical and microbiological features it has shown to be helpful in early diagnosis of VAP, but a study to show whether such early detection improves outcome is lacking.

Official Title
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Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of Ventilator Associated Pneumonia: a Diagnostic Randomized Controlled Trial.

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Diagnostic Test: lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanical ventilation for more than 48 hours Absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis) Exclusion Criteria: Recent trauma or surgery to the thorax (including chest tube insertion) Presence of dressings or skin conditions restricting access to the thorax Confirmed pregnancy If already enrolled in the study Denial of consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung ultrasound<br>Patients will be monitored for ventilator associated pneumonia using lung ultrasound combined with clinical features | Diagnostic Test: lung ultrasound<br>* lung ultrasound will be performed daily in mechanically ventilated patients after 48 hours of ventilation to screen for ventilator associated pneumonia<br>|
| No Intervention: Chest x-ray<br>Patients will be monitored for ventilator associated pneumonia using chest x-ray and clinical features. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator free days | number of days alive from day 1 (of VAP) to day 28 on which a patient breathes without assistance, if the period of unassisted breathing lasted at least 48 consecutive hours. If death occurs within 28 days then ventilator free days is counted as 0 | day 28 from diagnosis of VAP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| icu mortality | death during icu stay | through study completion, an average of 3 months | 
| icu length of stay | total duration of stay in icu | through study completion, an average of 3 months | 
| delta sofa | change in Sequential Organ Failure Score (SOFA) at day 4 of onset of VAP from the day of onset of VAP. SOFA ranges from 0 to 24. Delta sofa is the difference between SOFA score at day 4 from day 0 of VAP diagnosis. the higher the difference, the better the outcome | day 4 from VAP diagnosis | 
| ventilator days | total days the patient remains in mechanical ventilation | day 28 from intubation | 
| antibiotic duration | total days the patient receives antibiotics for VAP | day 14 from initiation of antibiotic | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventilator associated pneumonia, lung ultrasound