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

Not Applicable

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

• Registration Number: NCT02510105
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2015-06-01
• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-28
• Last Update Posted: 2015-07-28
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARDS patients	CT scan	-
ARDS patients	Ventilation ( with an ICU conventional ventilator)	-
ARDS patients	Servo-i	-
ARDS patients	VDR4 ventilator (Intrapulmonary Percussive Ventilation)	-
ARDS patients	- Intubation	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Volume of normally aerated lung	at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation)
Evolution of catecholamine doses (µg/Kg/min)	at day 1 (every 10 min between H0 and H1)
Volume of recruited lung	at day 1 (between H0 and H1)
Heart rate	at day 1 ((every 10 min between H0 and H1)

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France