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

NCT ID: NCT02510105

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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).

Conditions

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ARDS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARDS patients

Group Type EXPERIMENTAL

VDR4 ventilator (Intrapulmonary Percussive Ventilation)

Intervention Type DEVICE

CT scan

Intervention Type DEVICE

Servo-i

Intervention Type DEVICE

- Intubation

Intervention Type DEVICE

Ventilation ( with an ICU conventional ventilator)

Intervention Type DEVICE

Interventions

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VDR4 ventilator (Intrapulmonary Percussive Ventilation)

Intervention Type DEVICE

CT scan

Intervention Type DEVICE

Servo-i

Intervention Type DEVICE

- Intubation

Intervention Type DEVICE

Ventilation ( with an ICU conventional ventilator)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Estaing

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Michel CONSTANTIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

References

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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.

Reference Type DERIVED
PMID: 29325586 (View on PubMed)

Other Identifiers

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CHU-0236

Identifier Type: -

Identifier Source: org_study_id

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