NCT02885584

Brief Summary

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

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 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

Study Start

First participant enrolled

December 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

August 26, 2016

Last Update Submit

August 30, 2016

Conditions

ARDS

Keywords

Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Percent of patients exhibiting under HFPV an increase of at least 15% of normally aerated end-expiratory lung volume

    4 hours

Study Arms (2)

Transpulmonary pressure controlled mechanical ventilation

EXPERIMENTAL

transpulmonary pressure will be used for ventilation settings

Device: High frequency percussive ventilation

Conventional pressure-controlled mechanical ventilation

NO INTERVENTION

transpulmonary pressure will not be used for ventilation settings

Interventions

High frequency percussive ventilationDEVICE
Transpulmonary pressure controlled mechanical ventilation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique-Hôpitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • Urielle DESALBRES

    Assistance Publique-Hôpitaux de Marseille

    STUDY DIRECTOR

  • Antoine ROCH, MD/PhD

    Assistance Publique-Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

December 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)