Airway Pressure Release Ventilation as a Preventative Strategy - Full Text View

Sponsored by:	Texas Tech University Health Sciences Center
Information provided by:	Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00813371

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

MedlinePlus related topics: Injuries Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome

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 ]

Estimated Enrollment:	512
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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

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

Contacts

Contact: Ruth Gard, BS, RN

806-743-4222 ext 312

ruth.gard@ttuhsc.edu

Locations

United States, Texas
University Medical Center	Recruiting
Lubbock, Texas, United States, 79430
Principal Investigator: Jack Shannon, M.D.
Sub-Investigator: John Griswold, M.D.

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

Responsible Party:	Texas Tech University Health Sciences Center ( Jack Shannon, M.D. )
Study ID Numbers:	TTUHSC-L08-152
Study First Received:	December 22, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00813371
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

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Respiratory Distress Syndrome, Adult
Wounds and Injuries
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 13, 2009