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Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation (PRESSURE)

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ClinicalTrials.gov Identifier: NCT00793013
Recruitment Status : Withdrawn (IRB approval lapsed.)
First Posted : November 18, 2008
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Tennessee, Chattanooga

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 18, 2008
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE November 2, 2020
Actual Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
All cause mortality [ Time Frame: 28 days or prior to hospital discharge ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
all cause mortality [ Time Frame: 28 days or prior to hospital discharge ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
  • Number of ventilator-free days [ Time Frame: 28 days or prior to hospital discarge ]
  • Length of ICU stay and /or Total hospital days [ Time Frame: 28 days or prior to hospital discharge ]
  • To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the incidence of of AKI [ Time Frame: 28 days or prior to hospital discharge ]
  • To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the NGAL, KIM-1, and IL-18 urine biomarkers for AKI [ Time Frame: 28 days or prior to hospital discharge ]
  • To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation in maintaining hourly urine output > 0.5 mls/kg/hr [ Time Frame: 28 days or prior to hospital discharge ]
  • Will determine urinary aquaporin-2 levels in patients randomized to APRV ventilation versus ARDS net low volume-cycle ventilation [ Time Frame: 28 days or prior to hospital discharge ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation
Official Title  ICMJE Primary Resuscitation Using Airway Pressure Release Ventilation Improves Recovery From Acute Lung Injury or Adult Respiratory Distress Syndrome and Reduces All Cause Mortality Compared to ARDS Net Low Tidal Volume-Cycled Ventilation.
Brief Summary Traditional modes of ventilation have failed to improve patient survival. Subsequent observations that elevated airway pressures observed in traditional forms of ventilation resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled ventilation as a potentially better ventilatory modality for ARDS. Recent multicenter trials by the NIH-ARDS network have confirmed that low volume ventilation increases the number of ventilatory free days and improves overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.
Detailed Description Low volume ventilation may increase number of ventilatory free days and may improve overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Lung Injury
  • Adult Respiratory Distress Syndrome
  • Kidney Injury
Intervention  ICMJE
  • Device: Volume-Cycled Assist-Control (AC) mode
    1. Patients ventilated with volume-cycled assist-control mode with PEEP and goal FIO2 < 40%
    2. Rate of mandatory time-cycled, pressure controlled breaths,initially at 12 per breaths/min
    3. Initial tidal volume set at 8mL/kg using predicted body weight (PBW) with a goal of 6mL/kg & setting positive end-expiratory pressure (PEEP) based on level of initial FiO2
    4. Inspiratory to Expiratory ratio set at 1:1 to 1:3
    5. If frequency of triggered breaths increased greater than 10 per min sedation will be increased. If needed,rate of mandatory breaths increased
    6. Mgmt of PEEP will be conducted as per the ARDSnet Protocol
    7. Oxygenation goal PaO2: PaO2-55-80 mm Hg O2 Sat: 88-95%
    8. Tidal volume and respiratory rate adjusted to the desired pH and plateau pressures per ARDSnet protocol
    Other Name: Controlled Mechanical Ventilation (CMV)
  • Device: Airway Pressure Release Ventilation (APRV) mode
    1. Ventilation uses Drager Model X1
    2. Spontaneous breathing allowed throughout ventilatory cycle at 2 airway pressure levels
    3. Time periods for the high & low pressure levels can be set independently
    4. Duration of the lower pressure level will be adjusted to allow expiratory flow to decay to 75% of total volume
    5. Duration of higher pressure levels will be adjusted to produce 12 pressure shifts per min
    6. Spontaneous frequency will be targeted for 6 to 18 breaths/per min
    7. If spontaneous breathing is achieved,level of sedation will be decreased
    8. If spontaneous respirations are >20 breaths/min, sedation will be increased
    9. If spontaneous breathing frequency increased greater than 20/per min, sedation was increased and if needed the mechanical frequency increased
    Other Name: Controlled Mechanical Ventilation (CMV)
Study Arms  ICMJE
  • Experimental: ARDS Net Low Tidal Volume
    Intervention: Device: Volume-Cycled Assist-Control (AC) mode
  • Experimental: APRV Ventilation
    Intervention: Device: Airway Pressure Release Ventilation (APRV) mode
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2008)
368
Actual Study Completion Date  ICMJE November 2, 2020
Actual Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients admitted to the Internal Medicine service at the Baroness Erlanger Hospital of the University of Tennessee College of Medicine with hypoxia (O2 saturation < 93%) and pulmonary distress, will be screened for study participation.
  • Patients displaying all the following clinical criteria: acute onset of respiratory failure; hypoxia defined as a PaO2/FiO2 ratio of < 300 Torr; pulmonary capillary wedge pressure less or equal than 18 mm Hg, and/or no clinical evidence of left sided heart failure; and chest x-ray with diffuse bilateral pulmonary infiltrates.

Exclusion Criteria:

  • Patients receiving conventional volume ventilation with or without PEEP for > 6 hours prior to study enrollment
  • Patient's family or surrogate unwilling to give informed consent
  • Patients requiring sedation or paralysis for effective ventilation
  • Patients known pulmonary embolus within 72 hours of study enrollment
  • Patients with close head injuries or evidence of increased intracranial pressure
  • Patients with burns over 30% of total body surface area
  • Pulmonary capillary wedge pressure greater than 18 mm Hg
  • CVP > 15 cm H2O
  • Patients with B type Naturetic peptide levels > 1000
  • Patients with prior history of dilated cardiomyopathy with EF < 25%
  • Patients receiving chronic outpatient peritoneal or hemodialysis
  • Patients with severe liver disease (as defined by Child-Pugh class C)
  • AIDS patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793013
Other Study ID Numbers  ICMJE 123456789
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Tennessee, Chattanooga
Study Sponsor  ICMJE University of Tennessee, Chattanooga
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James A Tumlin, MD University of Tennessee
PRS Account University of Tennessee, Chattanooga
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP