Status:
COMPLETED
Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress Syndrome
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 mechan...
Detailed Description
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 approximat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00399581
Start Date
November 1 2006
End Date
June 1 2009
Last Update
February 27 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
University of Maryland Medical Center
Baltimore, Maryland, United States
4
Ohio State University Medical Center
Columbus, Ohio, United States