Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients

Study Overview
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Brief Summary
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The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).

Detailed Description
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Prospective clinical study in ICU of ventilated patients with ARDS. The morphologic pulmonary effects of IPV with VDR4 are not known to the investigators' knowledge. The main aim is to quantify recruited, normally aerated and overinflated parts of the lungs after a 1 hour treatment with IPV. Patients with ARDS (focal and non focal) consecutively admitted to the investigators' ICU are enrolled after informed consent. Patients are intubated and ventilated with Servo-I (GE) and ventilation is optimized according to ARDS-network recommandations. A first thoracic CT-scan is performed with ICU ventilator and then the patient is ventilated with VDR4 during 1 hour. A second thoracic CT-scan is then performed and the patient re-ventilated with ICU ventilator. Arterial blood gases and hemodynamic parameters are recorded during experiments. CT-scan are analysed and compared for normally aerated, overinflated and recruited lung parenchyma. Regions are determined thanks to their Hounsfield units (HU).

Official Title
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Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients

Conditions
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ARDS

Intervention / Treatment
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* Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation)
* Device: CT scan
* Device: Servo-i
* Device: - Intubation
* Device: Ventilation ( with an ICU conventional ventilator)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ventilated more than 48 h Sedated patients ARDS moderate or severe (Berlin 2012) Patients who have given their consent or his family Patients aged between 18 and 85 years Exclusion Criteria: Pregnant ou lactating women Hemodynamic instability Chronic respiratory insufficiency. Pneumothorax Fistulae bronchopleural

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARDS patients<br> | Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation)<br> <br> Device: CT scan<br> <br> Device: Servo-i<br> <br> Device: - Intubation<br> <br> Device: Ventilation ( with an ICU conventional ventilator)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (H0) in volume of overinflated lung at H1 |  | at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of normally aerated lung |  | at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation) | 
| Volume of recruited lung |  | at day 1 (between H0 and H1) | 
| Heart rate |  | at day 1 ((every 10 min between H0 and H1) | 
| Blood pressure |  | at day 1 (every 10 min between H0 and H1) | 
| Arterial blood gaz |  | at day 1 ((every 10 min between H0 and H1) | 
| Evolution of catecholamine doses (µg/Kg/min) |  | at day 1 (every 10 min between H0 and H1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Care, ARDS, Intrapulmonary Percussive Ventilation, VDR4, Lung aeration, CT scan