Chattanooga, Tennessee 37403


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.


Study summary:

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.


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


Study is Available At:


Original ID:

123456789


NCT ID:

NCT00793013


Secondary ID:


Study Acronym:

PRESSURE


Brief Title:

Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation


Official Title:

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.


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Tennessee, Chattanooga


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

368


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:James A Tumlin, MD
Principal Investigator
University of Tennessee
Primary Contact:James A Tumlin, MD
(423) 290-0882
JamesTumlinMD@Nephassociates.com
Backup Contact:Greg Nieckula, DO
(404) 704-2751
gnieckula@gmail.com

Study Dates

Start Date:November 2011
Completion Date:December 2015
Completion Type:Anticipated
Primary Completion Date:December 2015
Primary Completion Type:Anticipated
Verification Date:August 2015
Last Changed Date:August 10, 2015
First Received Date:November 17, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Length of ICU stay and /or Total hospital days
Time Frame:28 days or prior to hospital discharge
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of ventilator-free days
Time Frame:28 days or prior to hospital discarge
Safety Issues:False
Outcome Type:Primary Outcome
Measure:All cause mortality
Time Frame:28 days or prior to hospital discharge
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Volume-Cycled Assist-Control (AC) mode
Description:Patients ventilated with volume-cycled assist-control mode with PEEP and goal FIO2 < 40% Rate of mandatory time-cycled, pressure controlled breaths,initially at 12 per breaths/min 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 Inspiratory to Expiratory ratio set at 1:1 to 1:3 If frequency of triggered breaths increased greater than 10 per min sedation will be in
Arm Name:ARDS Net Low Tidal Volume
Other Name:Controlled Mechanical Ventilation (CMV)
Intervention Type:Device
Name:Airway Pressure Release Ventilation (APRV) mode
Description:Ventilation uses Drager Model X1 Spontaneous breathing allowed throughout ventilatory cycle at 2 airway pressure levels Time periods for the high & 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 min Spontaneous frequency will be targeted for 6 to 18 breaths/per min If spontaneous breathing is a
Arm Name:APRV Ventilation
Other Name:Controlled Mechanical Ventilation (CMV)

Study Arms

Study Arm Type:Experimental
Arm Name:APRV Ventilation
Study Arm Type:Experimental
Arm Name:ARDS Net Low Tidal Volume

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Tennessee, Chattanooga

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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