Airway Pressure Release Ventilation as a Preventative Strategy

Study Overview
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Brief Summary
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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.

Official Title
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Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome

Conditions
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Acute Respiratory Distress Syndrome, Acute Lung Injury, Respiratory Failure, Trauma

Intervention / Treatment
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* Device: Airway Pressure Release Ventilation
* Device: ARDSnet protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Airway Pressure Release Ventilation Arm | Device: Airway Pressure Release Ventilation<br>* Airway Pressure Release Ventilation (APRV) also known as Bi-Vent or Bi-Level ventilation is a time-cycled, pressure-limited mode of ventilation that allows spontaneous respiration throughout the ventilator cycle.<br>|
| Active Comparator: 2<br>ARDSnet protocol | Device: ARDSnet protocol<br>* ARDSnet protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be the number of ventilator-free days. |  | from randomization to study termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of ventilator mode on ventilation |  | duration of ventilatory assistance | 
| duration of ICU stay |  | time in ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Distress Syndrome, acute lung injury, Airway Pressure Release Ventilation, ARDSnet, Bi-level, respiratory failure, trauma, APRV