Airway Pressure Release Ventilation as a Preventative Strategy

This study has been withdrawn prior to enrollment.
(Principal Investigator left the institution before subjects were enrolled)
Sponsor:
Information provided by:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00813371
First received: December 22, 2008
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

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 Intervention
Acute Respiratory Distress Syndrome
Acute Lung Injury
Respiratory Failure
Trauma
Device: Airway Pressure Release Ventilation
Device: ARDSnet protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • The primary endpoint will be the number of ventilator-free days. [ Time Frame: from randomization to study termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effects of ventilator mode on ventilation [ Time Frame: duration of ventilatory assistance ] [ Designated as safety issue: No ]
  • duration of ICU stay [ Time Frame: time in ICU ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813371

Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Jack Shannon, M.D., Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00813371     History of Changes
Other Study ID Numbers: TTUHSC-L08-152
Study First Received: December 22, 2008
Last Updated: August 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Acute Respiratory Distress Syndrome
acute lung injury
Airway Pressure Release Ventilation
ARDSnet
Bi-level
respiratory failure
trauma
APRV

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

ClinicalTrials.gov processed this record on September 30, 2014