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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome

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.

Detailed Summary:

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. Participan
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • Number of ventilator free days [ Time Frame: Measured at 28 days ]
  • Changes in plasma concentration of IL-6 [ Time Frame: Measured at 3 days ]


Original Primary Outcome:

  • Number of ventilator free days
  • Changes in plasma concentration of IL-6 (both measured at Day 60 or until day of hospital discharge)


Current Secondary Outcome:

  • Number of intensive care unit free days [ Time Frame: Measured at 28 days ]
  • Mortality [ Time Frame: Measured at 60 days ]
  • Number of hospital free days [ Time Frame: Measured at 60 days ]
  • Changes in plasma IL1ra [ Time Frame: Measured at 3 days ]
  • Changes in plasma IL-1 [ Time Frame: Measured at 3 days ]
  • Changes in plasma IL-10 [ Time Frame: Measured at 3 days ]
  • Changes in plasma surfactant protein D [ Time Frame: Measured at 3 days ]
  • Changes in plasma von Willebrand factor [ Time Frame: Measured at 3 days ]


Original Secondary Outcome:

  • Number of intensive care unit free days
  • Mortality
  • Number of hospital free days
  • Changes in plasma IL1ra
  • Changes in plasma IL-1
  • Changes in plasma IL-10
  • Changes in plasma surfactant protein D
  • Changes in plasma von Willebrand factor (all measured at Day 60 or until day of hospital discharge)


Information By: Johns Hopkins University

Dates:
Date Received: November 14, 2006
Date Started: November 2006
Date Completion:
Last Updated: February 26, 2013
Last Verified: July 2009