Airway Pressure Release Ventilation as a Preventative Strategy

Overview

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.

Full Title of Study: “Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Interventions

  • Device: Airway Pressure Release Ventilation
    • 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.
  • Device: ARDSnet protocol
    • ARDSnet protocol

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Airway Pressure Release Ventilation Arm
  • Active Comparator: 2
    • ARDSnet protocol

Clinical Trial Outcome Measures

Primary Measures

  • The primary endpoint will be the number of ventilator-free days.
    • Time Frame: from randomization to study termination

Secondary Measures

  • effects of ventilator mode on ventilation
    • Time Frame: duration of ventilatory assistance
  • duration of ICU stay
    • Time Frame: time in ICU

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Texas Tech University Health Sciences Center
  • Provider of Information About this Clinical Study
    • Jack Shannon, M.D., Texas Tech University Health Sciences Center
  • Overall Official(s)
    • Jack Shannon, M.D., Principal Investigator, Texas Tech University Health Sciences Center
    • John Griswold, M.D., Study Director, Texas Tech University Health Sciences Center

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