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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02510105
Acronym
PERVE-ARDS
Enrollment
10
Registered
2015-07-28
Start date
2015-07-31
Completion date
2015-12-31
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

Critical Care, ARDS, Intrapulmonary Percussive Ventilation, VDR4, Lung aeration, CT scan

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).

Interventions

DEVICEServo-i
DEVICE- Intubation
DEVICEVentilation ( with an ICU conventional ventilator)
DEVICEVDR4 ventilator (Intrapulmonary Percussive Ventilation)
DEVICECT scan

Sponsors

University Hospital, Estaing
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline (H0) in volume of overinflated lung at H1at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation)

Secondary

MeasureTime frame
Volume of recruited lungat day 1 (between H0 and H1)
Heart rateat day 1 ((every 10 min between H0 and H1)
Volume of normally aerated lungat Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation)
Arterial blood gazat 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)
Blood pressureat day 1 (every 10 min between H0 and H1)

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026