Clinical trial NCT02510105: Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients
Official title: Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS
Keywords: Critical Care
ARDS
Intrapulmonary Percussive Ventilation
VDR4
Lung aeration
CT scan
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Estaing
First posted: 2015-07-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline (H0) in volume of overinflated lung at H1
timeFrame: at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation)
Secondary outcomes:
measure: Volume of normally aerated lung
timeFrame: at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation)
measure: Volume of recruited lung
timeFrame: at day 1 (between H0 and H1)
measure: Heart rate
timeFrame: at day 1 ((every 10 min between H0 and H1)
measure: Blood pressure
timeFrame: at day 1 (every 10 min between H0 and H1)
measure: Arterial blood gaz
timeFrame: at day 1 ((every 10 min between H0 and H1)
measure: Evolution of catecholamine doses (µg/Kg/min)
timeFrame: at day 1 (every 10 min between H0 and H1)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Michel CONSTANTIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.