Airway Pressure Release Ventilation as a Preventative Strategy

Texas Tech University Health Sciences Center

Status

Withdrawn

Conditions

Respiratory Failure

Trauma

Acute Lung Injury

Acute Respiratory Distress Syndrome

Treatments

Device: Airway Pressure Release Ventilation

Device: ARDSnet protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT00813371

TTUHSC-L08-152

Details and patient eligibility

About

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 faster recovery of lung function.

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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