Airway Pressure Release Ventilation as a Preventative Strategy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813371
Recruitment Status : Withdrawn (Principal Investigator left the institution before subjects were enrolled)
First Posted : December 23, 2008
Last Update Posted : August 25, 2009
Information provided by:
Texas Tech University Health Sciences Center

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 faster recovery of lung function.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Acute Lung Injury Respiratory Failure Trauma Device: Airway Pressure Release Ventilation Device: ARDSnet protocol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome
Study Start Date : December 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

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

Primary Outcome Measures :
  1. The primary endpoint will be the number of ventilator-free days. [ Time Frame: from randomization to study termination ]

Secondary Outcome Measures :
  1. effects of ventilator mode on ventilation [ Time Frame: duration of ventilatory assistance ]
  2. duration of ICU stay [ Time Frame: time in ICU ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813371

Sponsors and Collaborators
Texas Tech University Health Sciences Center
Principal Investigator: Jack Shannon, M.D. Texas Tech University Health Sciences Center
Study Director: John Griswold, M.D. Texas Tech University Health Sciences Center

Responsible Party: Jack Shannon, M.D., Texas Tech University Health Sciences Center Identifier: NCT00813371     History of Changes
Other Study ID Numbers: TTUHSC-L08-152
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Texas Tech University Health Sciences Center:
Acute Respiratory Distress Syndrome
acute lung injury
Airway Pressure Release Ventilation
respiratory failure

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries