NCT00308022

Brief Summary

This study is designed to exam the effects of early management with high frequency percussive ventilation (HFPV) on patients with lung injury. Patients at risk for Acute Respiratory Distress Syndrome (ARDS) will be enrolled and randomized to one of two groups. One group will be managed with HFPV. The second group will be managed with conventional ventilation utilizing lung protective techniques. The primary endpoint of the study is rate of ventilator associated pneumonia. We hypothesized that use of HFPV in patients at risk for the development of ARDS will decrease the rate of ventilator associated pneumonia when compared to patients managed with conventional ventilation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2009

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

March 24, 2006

Last Update Submit

January 15, 2019

Conditions

Respiratory Distress Syndrome, AdultPneumoniaMechanical Ventilation

Keywords

Acute Lung InjuryAcute Respiratory Distress SyndromeHigh Frequency Percussive VentilationVentilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Ventilator Associated Pneumonia

    28 days

Secondary Outcomes (3)

  • Cytokine profiles

    96 hours

  • Length of stay

    28 dyas

  • Ventilator Days

    28 days

Interventions

High Frequency Percussive VentilationDEVICE

Eligibility Criteria

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

You may qualify if:

  • PaO2/FiO2 \< 300 for less than 24 hours (Ratio of Partial pressure of oxygen to Fraction of inspired oxygen)

You may not qualify if:

  • Documented Pneumonia,
  • Documented Congestive Heart Failure,
  • Immunosuppression,
  • Enrolled in other interventional trial,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Respiratory Distress SyndromePneumoniaAcute Lung InjuryPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersRespiratory Tract InfectionsInfectionsLung InjuryHealthcare-Associated PneumoniaCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Randall Friese, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 31, 2009

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

US(1)