Airway Pressure Release Ventilation as a Preventative Strategy
Primary Purpose
Acute Respiratory Distress Syndrome, Acute Lung Injury, Respiratory Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Airway Pressure Release Ventilation
ARDSnet protocol
Sponsored by
About this trial
This is an interventional prevention trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, acute lung injury, Airway Pressure Release Ventilation, ARDSnet, Bi-level, respiratory failure, trauma, APRV
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Airway Pressure Release Ventilation Arm
ARDSnet protocol
Outcomes
Primary Outcome Measures
The primary endpoint will be the number of ventilator-free days.
Secondary Outcome Measures
effects of ventilator mode on ventilation
duration of ICU stay
Full Information
NCT ID
NCT00813371
First Posted
December 22, 2008
Last Updated
August 24, 2009
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT00813371
Brief Title
Airway Pressure Release Ventilation as a Preventative Strategy
Official Title
Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator left the institution before subjects were enrolled
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Lung Injury, Respiratory Failure, Trauma
Keywords
Acute Respiratory Distress Syndrome, acute lung injury, Airway Pressure Release Ventilation, ARDSnet, Bi-level, respiratory failure, trauma, APRV
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Airway Pressure Release Ventilation Arm
Arm Title
2
Arm Type
Active Comparator
Arm Description
ARDSnet protocol
Intervention Type
Device
Intervention Name(s)
Airway Pressure Release Ventilation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ARDSnet protocol
Intervention Description
ARDSnet protocol
Primary Outcome Measure Information:
Title
The primary endpoint will be the number of ventilator-free days.
Time Frame
from randomization to study termination
Secondary Outcome Measure Information:
Title
effects of ventilator mode on ventilation
Time Frame
duration of ventilatory assistance
Title
duration of ICU stay
Time Frame
time in ICU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Shannon, M.D.
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Griswold, M.D.
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Airway Pressure Release Ventilation as a Preventative Strategy
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