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

Completed · Phase 2

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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.

Key facts

Study ID

NCT00399581

Run by

Johns Hopkins University

People needed

100

Starts

2006-11-01

Expected to finish

2009-06-01

Last updated by the study team

2013-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• More than 72 hours has passed since inclusion criteria were met

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Wilford Hall Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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