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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Withdrawn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
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 22, 2008
    Last Updated
    August 24, 2009
    Sponsor
    Texas Tech University Health Sciences Center
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    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

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    Airway Pressure Release Ventilation as a Preventative Strategy

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