Acute Lung Injury Ventilator Evaluation (ALIVE)

Stopped early · Not applicable

Conditions studied: Acute Lung Injury, Adult Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT01901354

Run by

University of Wisconsin, Madison

People needed

4

Starts

2013-11-01

Expected to finish

2014-10-01

Last updated by the study team

2017-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.