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Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00399581
First received: November 14, 2006
Last updated: February 26, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome, Adult
Procedure: High Frequency Oscillatory Ventilation-Hi
Procedure: High Frequency Oscillatory Ventilation-Lo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Number of ventilator free days [ Time Frame: Measured at 28 days ] [ Designated as safety issue: No ]
  • Changes in plasma concentration of IL-6 [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of intensive care unit free days [ Time Frame: Measured at 28 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Measured at 60 days ] [ Designated as safety issue: No ]
  • Number of hospital free days [ Time Frame: Measured at 60 days ] [ Designated as safety issue: No ]
  • Changes in plasma IL1ra [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
  • Changes in plasma IL-1 [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
  • Changes in plasma IL-10 [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
  • Changes in plasma surfactant protein D [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
  • Changes in plasma von Willebrand factor [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2006
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HFOV-Lo
High Frequency Oscillatory Ventilation using lower mean airway pressures and higher FiO2s.
Procedure: High Frequency Oscillatory Ventilation-Lo
HFOV will be conducted without routine recruitment maneuvers and with a table of mPaw and FiO2s that include relatively low mPaw's.
Experimental: HFOV-Hi
High Frequency Oscillatory Ventilation using higher mean airway pressures
Procedure: High Frequency Oscillatory Ventilation-Hi
HFOV will be conducted with recruitment maneuvers and with a table of mPaw and FiO2s that include higher mPaw's.

Detailed Description:

ARDS is a serious condition that involves lung inflammation and fluid accumulation in the air sacs, leading to low blood oxygen levels and respiratory failure. It is often fatal and affects approximately 160,000 individuals each year in the United States. The main form of treatment for ARDS is delivery of oxygen and a continuous level of pressure to the damaged lungs through mechanical ventilation. However, some methods of mechanical ventilation may cause ventilator-associated lung injury (VALI), a condition that can result from overdistension of the lungs during inspiration or from excessive mechanical forces. VALI can delay or prevent healing from respiratory failure.

HFOV is a mechanical ventilation method that pumps small amounts of air into the lungs at a constant high rate. Because the increments of air are small the likelihood of experiencing overdistension and developing VALI may be reduced. While HFOV is an effective, commonly used ventilation method, there have been no studies that demonstrate the efficacy of HFOV in comparison to the efficacy of conventional mechanical ventilation methods. This study will compare two different HFOV techniques: the HFOV-Hi method, which uses higher airway pressure, and the HFOV-Lo method, which uses lower airway pressure. The purpose of this study is to compare the safety and efficacy of HFOV-Hi, HFOV-Lo, and standard mechanical ventilation methods in individuals with ARDS.

This study will enroll individuals with ARDS at four Baltimore hospitals. Participants will be randomly assigned to receive either HFOV-Hi or HFOV-Lo. All participants will receive their assigned HFOV method for 7 days, until spontaneous breathing occurs, or until death, whichever occurs first. Blood collected at baseline and Days 1 and 3 will be analyzed for markers of inflammation and lung injury. Participants' clinical status will be monitored until they no longer need ventilation and return home, or for up to 60 days while in the hospital. Individuals being treated for ARDS at the participating hospitals who decline to enroll in the study will be asked for permission to monitor their medical progress. These individuals will not take part in any study procedures, but their clinical information will be used for comparison purposes. Additionally, clinical information on other ARDS patients admitted to the hospital over the previous 2 years will be analyzed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute onset of all of the following criteria within a 24-hour period:

    1. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
    2. Requires positive pressure ventilation through an endotracheal tube
    3. 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
    4. No clinical evidence of left atrial hypertension

Exclusion Criteria:

  • 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
  • More than 72 hours has passed since inclusion criteria were met
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399581

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
University of Maryland Medical Center
Baltimore, Maryland, United States
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States
United States, Texas
Wilford Hall Medical Center
San Antonio, Texas, United States
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Roy G. Brower, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Roy Brower, MD, Professor of Medicine, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00399581     History of Changes
Other Study ID Numbers: 471, P50HL073994
Study First Received: November 14, 2006
Last Updated: February 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Acute Respiratory Distress Syndrome
Acute Lung Injury
Mechanical Ventilation
Lung

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014