Status:
WITHDRAWN
Airway Pressure Release Ventilation as a Preventative Strategy
Lead Sponsor:
Texas Tech University Health Sciences Center
Conditions:
Acute Respiratory Distress Syndrome
Acute Lung Injury
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows...
Eligibility Criteria
Inclusion
- Trauma patients age 16 or older
- Trauma patients requiring ventilatory support within 48 hours of injury
- Those with anticipated ventilatory support ≥ 24 hours
- Subject or authorized representative (AR) has signed an informed consent form (ICF)
- Subjects age 16 or 17 who have signed an assent document and/or AR has signed an ICF
Exclusion
- Significant chronic lung disease defined as lung pathology requiring home O2 use
- Chronic heart disease defined as NYHC III or higher
- Persistent bronchopulmonary air leak
- Contraindications to permissive hypercapnia (ex. Intracerebral bleeding, brain tumor, fulminant hepatic failure, and hemodynamic instability)
- Pulmonary artery occlusion pressures ≥ 18 mmHg
- Severe neurologic injury that may prevent the patient from having a reasonable opportunity for weaning as determined by the clinical study team
- Immuno-compromised patients secondary to drugs or disease
- Neuromuscular disease that impairs ability to ventilate spontaneously (ex. Spinal injury at or above C5, ALS, Guillain-Barre syndrome, Myasthenia Gravis)
- History of pneumonectomy
- Pregnancy
- Burns with TBSA ≥ 20%
- Acute MI as the cause of ALI/ARDS
- All other contraindications to APRV
- Patients who cannot be randomized within 12 hours of intubation
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00813371
Start Date
December 1 2008
End Date
December 1 2011
Last Update
August 25 2009
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