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