NCT00399581

Brief Summary

Acute respiratory distress syndrome (ARDS) is a severe lung condition that causes respiratory failure. Individuals with ARDS often require the use of an artificial breathing machine, known as a mechanical ventilator. High frequency oscillatory ventilation (HFOV) is a form of mechanical ventilation that pumps small amounts of air into the lungs at a constant high rate. The purpose of this study is to compare the safety and efficacy of two HFOV methods in individuals with ARDS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

5 active sites

Status
completed

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

November 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 27, 2013

Status Verified

July 1, 2009

Enrollment Period

2.5 years

First QC Date

November 14, 2006

Last Update Submit

February 26, 2013

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute Respiratory Distress SyndromeAcute Lung InjuryMechanical VentilationLung

Outcome Measures

Primary Outcomes (2)

  • Number of ventilator free days

    Measured at 28 days

  • Changes in plasma concentration of IL-6

    Measured at 3 days

Secondary Outcomes (8)

  • Number of intensive care unit free days

    Measured at 28 days

  • Mortality

    Measured at 60 days

  • Number of hospital free days

    Measured at 60 days

  • Changes in plasma IL1ra

    Measured at 3 days

  • Changes in plasma IL-1

    Measured at 3 days

  • +3 more secondary outcomes

Study Arms (2)

HFOV-Lo

EXPERIMENTAL

High Frequency Oscillatory Ventilation using lower mean airway pressures and higher FiO2s.

Procedure: High Frequency Oscillatory Ventilation-Lo

HFOV-Hi

EXPERIMENTAL

High Frequency Oscillatory Ventilation using higher mean airway pressures

Procedure: High Frequency Oscillatory Ventilation-Hi

Interventions

High Frequency Oscillatory Ventilation-HiPROCEDURE

HFOV will be conducted with recruitment maneuvers and with a table of mPaw and FiO2s that include higher mPaw's.

HFOV-Hi
High Frequency Oscillatory Ventilation-LoPROCEDURE

HFOV will be conducted without routine recruitment maneuvers and with a table of mPaw and FiO2s that include relatively low mPaw's.

HFOV-Lo

Eligibility Criteria

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

You may qualify if:

  • Acute onset of all of the following criteria within a 24-hour period:
  • Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
  • Requires positive pressure ventilation through an endotracheal tube
  • PaO2/FiO2 less than 200 while receiving positive end-expiratory pressure (PEEP) at more than 8 cm H2O for at least 4 hours, with a duration of no more than 7 days
  • No clinical evidence of left atrial hypertension

You may not qualify if:

  • Weighs less than 35 kilograms
  • Receives more than 5 days of mechanical ventilation during current hospitalization
  • Attending physician declines to give consent for participant to enroll
  • Patient or surrogate declines or is unable to give consent
  • Participation in another interventional study for ARDS in the 30 days prior to study entry
  • Intracranial hypertension
  • Single lung transplant
  • Burns over more than 30% of the surface area of the body
  • Pregnant
  • Sickle (Hgb SS) or sickle-thal (Hgb SC) hemoglobin
  • Pre-existing illness with a life expectancy of 6 months or less
  • Physicians and family are not committed to full support (Exception: An individual will not be excluded if he/she would receive all medical care except for attempts at resuscitation from cardiac arrest)
  • Severe chronic lung disease
  • Prior lung resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, United States

Location

Ohio State University Medical Center

Columbus, Ohio, United States

Location

Wilford Hall Medical Center

San Antonio, Texas, United States

Location

Related Publications (5)

  • Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.

    PMID: 16236739BACKGROUND

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PMID: 10793162BACKGROUND

  • Krishnan JA, Brower RG. High-frequency ventilation for acute lung injury and ARDS. Chest. 2000 Sep;118(3):795-807. doi: 10.1378/chest.118.3.795.

    PMID: 10988205BACKGROUND

  • Derdak S, Mehta S, Stewart TE, Smith T, Rogers M, Buchman TG, Carlin B, Lowson S, Granton J; Multicenter Oscillatory Ventilation For Acute Respiratory Distress Syndrome Trial (MOAT) Study Investigators. High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults: a randomized, controlled trial. Am J Respir Crit Care Med. 2002 Sep 15;166(6):801-8. doi: 10.1164/rccm.2108052.

    PMID: 12231488BACKGROUND

  • Randomized study of high-frequency oscillatory ventilation in infants with severe respiratory distress syndrome. HiFO Study Group. J Pediatr. 1993 Apr;122(4):609-19. doi: 10.1016/s0022-3476(05)83548-6.

    PMID: 8463913BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Study Officials

  • Roy G. Brower, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

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

November 14, 2006

First Posted

November 15, 2006

Study Start

November 1, 2006

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

February 27, 2013

Record last verified: 2009-07

Locations

US(5)