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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Tennessee, Chattanooga
Sponsor:
Information provided by (Responsible Party):
James A. Tumlin, MD, University of Tennessee, Chattanooga
ClinicalTrials.gov Identifier:
NCT00793013
First received: November 17, 2008
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Acute Lung Injury
Adult Respiratory Distress Syndrome
Kidney Injury
Device: Volume-Cycled Assist-Control (AC) mode
Device: Airway Pressure Release Ventilation (APRV) mode

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Resuscitation Using Airway Pressure Release Ventilation (APRV) Improves Recovery From Acute Lung Injury (ALI) or Adult Respiratory Distress Syndrome (ARDS) and Reduces All Cause Mortality Compared to ARDS Net Low Tidal Volume-Cycled Ventilation. PRESSURE Trial

Resource links provided by NLM:


Further study details as provided by University of Tennessee, Chattanooga:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 28 days or prior to hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of ventilator-free days [ Time Frame: 28 days or prior to hospital discarge ] [ Designated as safety issue: No ]
  • Length of ICU stay and /or Total hospital days [ Time Frame: 28 days or prior to hospital discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 368
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARDS Net Low Tidal Volume 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)
Experimental: APRV Ventilation 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793013

Contacts
Contact: James A Tumlin, MD (423) 290-0882 JamesTumlinMD@Nephassociates.com
Contact: Greg Nieckula, DO (404) 704-2751 gnieckula@gmail.com

Locations
United States, Tennessee
James A. Tumlin, MD Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: James A Tumlin, MD    423-290-0882    JamesTumlinMD@Nephassociates.com   
Sponsors and Collaborators
University of Tennessee, Chattanooga
Investigators
Principal Investigator: James A Tumlin, MD University of Tennessee
  More Information

No publications provided

Responsible Party: James A. Tumlin, MD, Principal Investigator, University of Tennessee, Chattanooga
ClinicalTrials.gov Identifier: NCT00793013     History of Changes
Other Study ID Numbers: 123456789
Study First Received: November 17, 2008
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee, Chattanooga:
Acute Lung Injury
Adult Respiratory Distress Syndrome
Airway Pressure Release Ventilation
Acute Kidney Injury
Pressure Trial

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014