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

ARDS Clinical Trial

— PERVE-ARDS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02510105
• Other study ID #: CHU-0236
• Status: Not yet recruiting
• Phase: N/A
• First received: June 1, 2015
• Last updated: July 27, 2015
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ARDS

Intervention

Device:
• VDR4 ventilator (Intrapulmonary Percussive Ventilation)

• CT scan

• Servo-i

• - Intubation

• Ventilation ( with an ICU conventional ventilator)

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	University Hospital, Estaing

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Volume of normally aerated lung		at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation)	No
Secondary	Volume of recruited lung		at day 1 (between H0 and H1)	No
Secondary	Heart rate		at day 1 ((every 10 min between H0 and H1)	No
Secondary	Blood pressure		at day 1 (every 10 min between H0 and H1)	No
Secondary	Arterial blood gaz		at day 1 ((every 10 min between H0 and H1)	No
Secondary	Evolution of catecholamine doses (µg/Kg/min)		at day 1 (every 10 min between H0 and H1)	No