Status:
TERMINATED
Airway Pressure Release Ventilation in Acute Lung Injury
Lead Sponsor:
Johns Hopkins University
Conditions:
Acute Lung Injury
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare airway pressure release ventilation (APRV) to conventional mechanical ventilation (MV) in patients with acute lung injury (ALI) to determine if APRV can reduce ...
Detailed Description
Acute respiratory failure is common in patients with acute lung injury. MV re-establishes adequate gas exchange; it allows time for administration of antibiotics, for the host's immune system to fight...
Eligibility Criteria
Inclusion
- Acute onset of:
- Arterial Pressure of Oxygen (PaO2) / FiO2 ≤ 300
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric
- Requirement for positive pressure ventilation via endotracheal tube, and
- No clinical evidence of left atrial hypertension.
- Receiving conventional MV, or lung-protective ventilation (LPV), in the assist control (AC) mode with positive end-expiratory pressure (PEEP) \> 5 cm H2O Criteria 1-3 must occur within a 24-hour period. "Acute onset" is defined as follows: the duration of the hypoxemia criterion (#1) and the chest radiograph criterion (#2) must be \< 7 days at the time of randomization.
Exclusion
- FiO2 \> 70% or PaO2/FiO2 \< 125 or arterial pH \< 7.25
- Greater than 6 days since all inclusion criteria are met
- Anticipated to begin weaning from MV within 48 hours
- Neuromuscular disease that prevents the ability to generate spontaneous tidal volumes.
- Glasgow Coma Scale (GCS) \< 15 within 1 week of intubation
- Acute stroke (vascular occlusion or hemorrhage)
- Current alcoholism or previous daily use of opioids or benzodiazepines before hospitalization
- Acute meningitis or encephalitis
- Pregnancy (negative pregnancy test required for women of child-bearing potential) or breast-feeding.
- Severe chronic respiratory disease
- Previous barotraumas during the current hospitalization
- Clinical evidence of bronchoconstriction on bedside examination (i.e., wheezing).
- Patient, surrogate, or physician not committed to full support
- Severe chronic liver disease (Child-Pugh Score B or C)
- International Normalized Ratio (INR) \> 2.0
- Platelet level \< 50,000
- Mean arterial pressure \< 65, or patient receiving intravenous vasopressors (any dose of epinephrine, norepinephrine, phenylephrine, or dopamine \> 5 mcg/kg/min)
- Age \< 16 years old
- Morbid obesity (greater than 1kg/cm body weight).
- No consent/inability to obtain consent
- Unwillingness of the clinical team to use conventional low tidal-volume protocol for MV.
- Moribund patient not expected to survive 24 hours.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00750204
Start Date
July 1 2008
End Date
October 15 2008
Last Update
May 15 2017
Active Locations (1)
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1
Johns Hopkins Hospital Medical Intensive Care Unit
Baltimore, Maryland, United States, 21205