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
Verified date | July 2009 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Derdak S, Mehta S, Stewart TE, Smith T, Rogers M, Buchman TG, Carlin B, Lowson S, Granton J; Multicenter Oscillatory Ventilation For Acute Respiratory Distress Syndrome Trial (MOAT) Study Investigators. High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults: a randomized, controlled trial. Am J Respir Crit Care Med. 2002 Sep 15;166(6):801-8. — View Citation
Krishnan JA, Brower RG. High-frequency ventilation for acute lung injury and ARDS. Chest. 2000 Sep;118(3):795-807. Review. — View Citation
Randomized study of high-frequency oscillatory ventilation in infants with severe respiratory distress syndrome. HiFO Study Group. J Pediatr. 1993 Apr;122(4):609-19. — View Citation
Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. — View Citation
Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med. 2000 May 4;342(18):1301-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of ventilator free days | Measured at 28 days | No | |
Primary | Changes in plasma concentration of IL-6 | Measured at 3 days | No | |
Secondary | Number of intensive care unit free days | Measured at 28 days | No | |
Secondary | Mortality | Measured at 60 days | No | |
Secondary | Number of hospital free days | Measured at 60 days | No | |
Secondary | Changes in plasma IL1ra | Measured at 3 days | No | |
Secondary | Changes in plasma IL-1 | Measured at 3 days | No | |
Secondary | Changes in plasma IL-10 | Measured at 3 days | No | |
Secondary | Changes in plasma surfactant protein D | Measured at 3 days | No | |
Secondary | Changes in plasma von Willebrand factor | Measured at 3 days | No |
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