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This study has been withdrawn prior to enrollment.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:
Texas Tech University Health Sciences Center
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
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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
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:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Respiratory Insufficiency Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013