Conventional Mechanical Ventilation and High Frequency Percussive Ventilation: Comparison of Their Effects on Alveolar Recruitment and Distension by CT-scan in Early ARDS Patients

August 30, 2016 updated by: Assistance Publique Hopitaux De Marseille
High frequency percussive ventilation (HFPV) is a high frequency ventilation mode in which high frequency pulses accumulate to generate a low frequency tidal volume at a controlled airway pressure. Previous studies have suggested a protective effect of HFPV on lung injury. The goal of our study is to compare, in early ARDS patients, the effects of conventional mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment and distension evaluated by CT-scan

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique-Hôpitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient undergoing invasive ventilation for more than 24h
  • ARDS patient

Exclusion Criteria:

  • Pneumothorax drained or not
  • Patient undergoing extracorporel mechanical oxygenation
  • Patient who had a pneumonectomy partiel or total

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transpulmonary pressure controlled mechanical ventilation
transpulmonary pressure will be used for ventilation settings
Device: High frequency percussive ventilation
NO_INTERVENTION: Conventional pressure-controlled mechanical ventilation
transpulmonary pressure will not be used for ventilation settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of patients exhibiting under HFPV an increase of at least 15% of normally aerated end-expiratory lung volume
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Assistance Publique-Hôpitaux de Marseille
  • Principal Investigator: Antoine ROCH, MD/PhD, Assistance Publique-Hôpitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (ESTIMATE)

August 31, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-11
  • 2013-A00465-40 (OTHER: Ansm)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ARDS

Clinical Trials on High frequency percussive ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe