- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901354
Acute Lung Injury Ventilator Evaluation (ALIVE) (ALIVE)
Acute Lung Injury Ventilator Evaluation (ALIVE) Trial: Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation in Trauma Patients
This study will compare two ventilator modes in mechanically ventilated patients with acute lung injury.
Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI. ALI causes 75,000 deaths in the US each year.
Ventilators can be set to work in different ways, called modes. One mode, called ARDSNet, pumps a small amount of air into the patient's lungs and then most of the air is released prior to the next breath. Another mode, called Airway pressure release ventilation (APRV), keeps air in the lungs longer between breaths. Both of these modes are currently used at this hospital. The investigators think APRV may help patients with ALI, but we do not know for sure.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin-Madison
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age greater than or equal to 18
- Admitted to intensive care unit
- Has legally authorized representative (LAR) available to provide informed consent in languages allowed by IRB
- Has required mechanical ventilator for less than 14 days
- Meets all of the following American-European Consensus Criteria for Acute Lung Injury or Acute Respiratory Distress Syndrome: a. Acute onset of respiratory compromise, AND b. Bilateral chest radiographic infiltrates, AND c. PaO2/FiO2 ratio less than 300, OR if no arterial blood gas has been drawn by the clinical care team, a saturation O2/FiO2 ratio less than 315 with an O2 saturation less than 97%), AND d. Known pulmonary wedge pressure less than 18 mmHg, OR if pulmonary wedge pressure is not known, left-sided heart failure is not the most likely explanation for the patient's clinical findings of bilateral infiltrates and/or low PaO2/FiO2 ratio
- Has met ALI criteria for less than 7 days prior to enrollment
- Approval of intensive care unit attending physician
- Has arterial catheter in place
- Meets Clinical Stability Criteria for at least one hour prior to the start of study procedures. Note: Clinical Stability Criteria must be maintained throughout the duration of the intervention period.
Exclusion Criteria:
- Patient has a Do Not Resuscitate Order
- Evidence of increased intracranial pressure (e.g. presence of intraventricular catheter, brain herniation)
- Patient is pregnant (if pregnancy test was not performed as part of routine clinical care, a urine pregnancy test must be performed for women of childbearing potential after informed consent obtained)
- Planned transport out of ICU during study protocol
- Coagulopathy within the past 48 hours (INR greater than 2.0 or PTT greater than 50 seconds)
- Severe thrombocytopenia within the past 48 hours (platelets less than 20,000 per μL)
- History of obstructive lung disease (asthma and/or COPD)
- Patients who are currently prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Low-tidal-volume ventilation
Subjects will be ventilated with a goal tidal volume of 6 cc/kg predicted body weight (PBW), a goal plateau pressure of <30 cm H2O, and a goal respiratory rate of 6-35 bpm to achieve a goal arterial pH of 7.30 to 7.45.
Positive end-expiratory pressure is set as per the ARDSNet Positive end-expiratory pressure table
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Goal tidal volume is 6 cc/kg ideal body weight.
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ACTIVE_COMPARATOR: Airway pressure release ventilation (APRV)
Airway Pressure Release Ventilation (APRV) is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing throughout the respiratory cycle. Initial settings: Pressure high will be set initially to equal the plateau pressure on baseline ARDSNet settings. Time low will be set to 0.5-0.8 seconds to achieve an end expiratory flow 25-50% of peak expiratory flow, and Time high will be set to obtain a set respiratory rate 60%-70% that of baseline settings. Time high will be adjusted to achieve similar continuous exhaled carbon dioxide levels as baseline ARDSNet settings. Low pressure will be set at <5 cm H20. |
APRV is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing through the respiratory cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6 (IL-6)
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6(IL-6), a biomarker that has been shown to correlate with degree of lung inflammation.
The study will be powered to detect a decrease in plasma IL-6 levels (pg/mL) from ARDSNet to APRV.
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Baseline, Hour 6, Hour 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Soluble receptors of tumor necrosis factor alpha (sTNFa-R1)
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Soluble receptors of tumor necrosis factor alpha (sTNFa-R1) that we speculate will correlate with degree of lung inflammation.
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon static lung compliance (L/cmH2O).
Time Frame: Baseline, Hour 6, Hour 12
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Static lung compliance in L/cmH2O will be recorded for each subject at baseline, Hour 6 and Hour 12.
We will assess the impact of APRV and ARDSNet ventilator modes upon static lung compliance by comparing change from baseline measurement to Hour 6 measurement with change from baseline measurement to Hour 12 measurement.
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-8 (IL-8)
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-8 (IL-8) that we speculate will correlate with degree of lung inflammation.
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-1 receptor antagonist (IL1-r-a)
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-1 receptor antagonist (IL1-r-a) that we speculate will correlate with degree of lung inflammation.
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon plasma expression of Surfactant, pulmonary-associated protein D (SP-D)
Time Frame: Baseline, 6 Hours, 12 Hours
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We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Surfactant, pulmonary-associated protein D (SP-D) that we speculate will correlate with degree of lung inflammation.
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Baseline, 6 Hours, 12 Hours
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Impact of APRV and ARDSNet ventilator modes upon Oxygenation (PaO2)
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon Oxygenation (PaO2).
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon Ventilation (PaCO2)
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon Ventilation (PaCO2).
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon Tissue metabolism (lactate)
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon Tissue metabolism (lactate).
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon Non-spontaneous tidal volumes
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon non-spontaneous tidal volumes.
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon sedation utilized
Time Frame: Baseline, Hour 6, Hour 12
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We will assess the impact of APRV and ARDSNet ventilator modes upon sedation utilized.
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon Riker Sedation-Agitation Scale score
Time Frame: Baseline, Hour 6, Hour 12
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Agitation will be recorded according to the Riker Sedation-Agitation Scale on a scale of 1 to 7 (un-arousable to dangerous agitation) for each subject at baseline, Hour 6 and Hour 12.
We will assess the impact of APRV and ARDSNet ventilator modes upon Riker Sedation-Agitation Score by comparing change from baseline measurement to Hour 6 measurement with change from baseline measurement to Hour 12 measurement.
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Baseline, Hour 6, Hour 12
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Impact of APRV and ARDSNet ventilator modes upon Cardiac output
Time Frame: Baseline, Hour 6, Hour 12
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Cardiac output will be recorded for each subject at sites with appropriate equipment at baseline, Hour 6 and Hour 12.
The unit of measure for cardiac output will depend on the equipment used to measure the subject.
However, the same equipment will be used for each subject, so the following will be calculable: change from baseline measurement to Hour 6 measurement with change from baseline measurement to Hour 12 measurement.
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Baseline, Hour 6, Hour 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suresh Agarwal, MD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-0887
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