Status:
TERMINATED
Acute Lung Injury Ventilator Evaluation (ALIVE)
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Acute Lung Injury
Adult Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01901354
Start Date
November 1 2013
End Date
October 1 2014
Last Update
September 28 2017
Active Locations (1)
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1
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792