Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress Syndrome
|ClinicalTrials.gov Identifier: NCT00399581|
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : February 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Adult||Procedure: High Frequency Oscillatory Ventilation-Hi Procedure: High Frequency Oscillatory Ventilation-Lo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome|
|Study Start Date :||November 2006|
|Primary Completion Date :||May 2009|
|Study Completion Date :||June 2009|
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.
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.
- Number of ventilator free days [ Time Frame: Measured at 28 days ]
- Changes in plasma concentration of IL-6 [ Time Frame: Measured at 3 days ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399581
|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|
|Principal Investigator:||Roy G. Brower, MD||Johns Hopkins University|