Airway Pressure Release Ventilation as a Preventative Strategy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Respiratory Failure; Trauma; Acute Respiratory Distress Syndrome; Acute Lung Injury
• Intervention / Treatment: Device: Airway Pressure Release Ventilation; Device: ARDSnet protocol

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Airway Pressure Release Ventilation Arm	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.
Active Comparator: 2; ARDSnet protocol	Device: ARDSnet protocol; ARDSnet protocol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Jack Shannon, M.D., Texas Tech University Health Sciences Center; Study Director: John Griswold, M.D., Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: December 22, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (Estimate): December 23, 2008

Study Record Updates

• Last Update Posted (Estimate): August 25, 2009
• Last Update Submitted That Met QC Criteria: August 24, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: trauma; respiratory failure; Airway Pressure Release Ventilation; Acute Respiratory Distress Syndrome; acute lung injury; ARDSnet; Bi-level; APRV
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Syndrome; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: TTUHSC-L08-152

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No