NCT02510105

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

June 1, 2015

Last Update Submit

July 27, 2015

Conditions

ARDS

Keywords

Critical CareARDSIntrapulmonary Percussive VentilationVDR4Lung aerationCT scan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (1)

ARDS patients

EXPERIMENTAL
Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation)Device: CT scanDevice: Servo-iDevice: - IntubationDevice: Ventilation ( with an ICU conventional ventilator)

Interventions

VDR4 ventilator (Intrapulmonary Percussive Ventilation)DEVICE
ARDS patients
CT scanDEVICE
ARDS patients
Servo-iDEVICE
ARDS patients
- IntubationDEVICE
ARDS patients
Ventilation ( with an ICU conventional ventilator)DEVICE
ARDS patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant ou lactating women
  • Hemodynamic instability
  • Chronic respiratory insufficiency.
  • Pneumothorax
  • Fistulae bronchopleural

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 29325586DERIVED

MeSH Terms

Interventions

Tomography, X-Ray ComputedIntubation

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomographyTherapeuticsInvestigative Techniques

Study Officials

  • Jean-Michel CONSTANTIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

July 28, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

FR(1)