Acute Lung Injury Ventilator Evaluation (ALIVE)

Launched by UNIVERSITY OF WISCONSIN, MADISON · Jul 12, 2013

Keywords

ClinConnect Summary

Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a spectrum of clinical syndromes of rapid respiratory system deterioration that are associated with both pulmonary and systemic illness. These syndromes are associated with 30-40% mortality with our current standard of care and are responsible for approximately 75,000 deaths in the US yearly. The current evidence-based care consists of a strategy of mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit further lung injury from overstretch of the lung induced by the ventil...

Gender

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Eligibility criteria

• 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