Airway Pressure Release Ventilation (APRV) is Superior to ARDS Net Low Tidal Volume-Cycled Ventilation in ALI/ARDS Patients - Full Text View

Sponsored by:	University of Tennessee, Chattanooga
Information provided by:	University of Tennessee, Chattanooga
ClinicalTrials.gov Identifier:	NCT00793013

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 Tital Volume-Cycled Ventilation. PRESSURE Trial

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:	December 2008

Arms	Assigned Interventions
ARDS Net Low Tidal Volume: Experimental	Device: Volume-Cycled Assist-Control (AC) mode Patients will be ventilated with volume-cycled assist-control mode with PEEP and goal FIO2 < 40% Rate of mandatory time-cycled, pressure controlled breaths, will be set initially at 12 per breaths/minute Initial tidal volume will be set at 8 mL/kg using predicted body weight (PBW) with a goal of 6 mL/kg and setting positive end-expiratory pressure (PEEP) based on level of initial FiO2 Inspiratory to Expiratory ratio will be set at 1:1 to 1:3 If frequency of triggered breaths increased greater than 10 per minute, sedation will be increased and, if needed, the rate of mandatory breaths increased Management of PEEP will be conducted as per the ARDSnet Protocol Oxygenation goal PaO2: PaO2-55-80 mm Hg O2 Sat: 88-95% Tidal volume and respiratory rate will be adjusted to the desired pH and plateau pressures per ARDSnet protocal
APRV Ventilation: Experimental	Device: Airway Pressure Release Ventilation (APRV) mode Ventilation will be accomplished using a Drager Model X1 Spontaneous breathing will be allowed throughout the entire ventilatory cycle at two airway pressure levels Time periods for the high and low pressure levels can be set independently Duration of the lower pressure level will be adjusted to allow expiratory flow to decay to 75% of total volume Duration of higher pressure levels will be adjusted to produce 12 pressure shifts per minute Spontaneous frequency will be targeted for 6 to 18 breaths/ per minute If spontaneous breathing was not achieved, the level of sedation will be decreased If spontaneous respirations are > 20 breaths/min, sedation will be increased If spontaneous breathing frequency increased greater than 20 per minute, sedation was increased and if needed the mechanical frequency increased

Arms

Assigned Interventions

ARDS Net Low Tidal Volume: Experimental

Device: Volume-Cycled Assist-Control (AC) mode

Patients will be ventilated with volume-cycled assist-control mode with PEEP and goal FIO2 < 40%
Rate of mandatory time-cycled, pressure controlled breaths, will be set initially at 12 per breaths/minute
Initial tidal volume will be set at 8 mL/kg using predicted body weight (PBW) with a goal of 6 mL/kg and setting positive end-expiratory pressure (PEEP) based on level of initial FiO2
Inspiratory to Expiratory ratio will be set at 1:1 to 1:3
If frequency of triggered breaths increased greater than 10 per minute, sedation will be increased and, if needed, the rate of mandatory breaths increased
Management of PEEP will be conducted as per the ARDSnet Protocol
Oxygenation goal PaO2: PaO2-55-80 mm Hg O2 Sat: 88-95%
Tidal volume and respiratory rate will be adjusted to the desired pH and plateau pressures per ARDSnet protocal

APRV Ventilation: Experimental

Device: Airway Pressure Release Ventilation (APRV) mode

Ventilation will be accomplished using a Drager Model X1
Spontaneous breathing will be allowed throughout the entire ventilatory cycle at two airway pressure levels
Time periods for the high and low pressure levels can be set independently
Duration of the lower pressure level will be adjusted to allow expiratory flow to decay to 75% of total volume
Duration of higher pressure levels will be adjusted to produce 12 pressure shifts per minute
Spontaneous frequency will be targeted for 6 to 18 breaths/ per minute
If spontaneous breathing was not achieved, the level of sedation will be decreased
If spontaneous respirations are > 20 breaths/min, sedation will be increased
If spontaneous breathing frequency increased greater than 20 per minute, sedation was increased and if needed the mechanical frequency increased

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

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

Contacts

Contact: James A Tumlin, MD	(423) 290-0882	JamesTumlinMD@Nephassociates.com
Contact: William E Kyle, DO	(404) 704-2751	drwkyle@yahoo.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	Unaffiliated
Study Director:	William E Kyle, DO	University of Tennessee

More Information

Responsible Party:	Department of Medicine, University of Tennessee Chattanooga ( James A. Tumlin, MD )
Study ID Numbers:	123456789
Study First Received:	November 17, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00793013
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

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009