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

Primary Purpose

Acute Lung Injury, Adult Respiratory Distress Syndrome, Kidney Injury

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Volume-Cycled Assist-Control (AC) mode
Airway Pressure Release Ventilation (APRV) mode
Sponsored by
University of Tennessee, Chattanooga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring Acute Lung Injury, Adult Respiratory Distress Syndrome, Airway Pressure Release Ventilation, Acute Kidney Injury, Pressure Trial

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James A. Tumlin, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ARDS Net Low Tidal Volume

APRV Ventilation

Arm Description

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Number of ventilator-free days
Length of ICU stay and /or Total hospital days
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the incidence of of AKI
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
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation in maintaining hourly urine output > 0.5 mls/kg/hr
Will determine urinary aquaporin-2 levels in patients randomized to APRV ventilation versus ARDS net low volume-cycle ventilation

Full Information

First Posted
November 17, 2008
Last Updated
November 2, 2020
Sponsor
University of Tennessee, Chattanooga
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1. Study Identification

Unique Protocol Identification Number
NCT00793013
Brief Title
Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation
Acronym
PRESSURE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
IRB approval lapsed.
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee, Chattanooga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Adult Respiratory Distress Syndrome, Kidney Injury
Keywords
Acute Lung Injury, Adult Respiratory Distress Syndrome, Airway Pressure Release Ventilation, Acute Kidney Injury, Pressure Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARDS Net Low Tidal Volume
Arm Type
Experimental
Arm Title
APRV Ventilation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Volume-Cycled Assist-Control (AC) mode
Other Intervention Name(s)
Controlled Mechanical Ventilation (CMV)
Intervention 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 increased. If needed,rate of mandatory breaths increased Mgmt 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 adjusted to the desired pH and plateau pressures per ARDSnet protocol
Intervention Type
Device
Intervention Name(s)
Airway Pressure Release Ventilation (APRV) mode
Other Intervention Name(s)
Controlled Mechanical Ventilation (CMV)
Intervention 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 achieved,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 min, sedation was increased and if needed the mechanical frequency increased
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
28 days or prior to hospital discharge
Secondary Outcome Measure Information:
Title
Number of ventilator-free days
Time Frame
28 days or prior to hospital discarge
Title
Length of ICU stay and /or Total hospital days
Time Frame
28 days or prior to hospital discharge
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Tumlin, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Tumlin, MD
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

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Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation

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