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

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).

Study Overview

• Status: Unknown
• Conditions: ARDS
• Intervention / Treatment: Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation); Device: CT scan; Device: Servo-i; Device: - Intubation; Device: Ventilation ( with an ICU conventional ventilator)

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Estaing

Publications and helpful links

General Publications

• Godet T, Jabaudon M, Blondonnet R, Tremblay A, Audard J, Rieu B, Pereira B, Garcier JM, Futier E, Constantin JM. High frequency percussive ventilation increases alveolar recruitment in early acute respiratory distress syndrome: an experimental, physiological and CT scan study. Crit Care. 2018 Jan 11;22(1):3. doi: 10.1186/s13054-017-1924-6.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: ARDS; Critical Care; CT scan; Intrapulmonary Percussive Ventilation; VDR4; Lung aeration
• Other Study ID Numbers: CHU-0236