Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients (PERVE-ARDS)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: ARDS

Treatments: Device: Ventilation ( with an ICU conventional ventilator); Device: CT scan; Device: - Intubation; Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation); Device: Servo-i

Study type: Interventional

Funder types: Other

Identifiers

NCT02510105

CHU-0236

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ARDS patients

Experimental group

Treatment:

Device: CT scan

Device: Ventilation ( with an ICU conventional ventilator)

Device: Servo-i

Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation)

Device: - Intubation