The National Heart, Lung, and Blood Institute of the National Institutes of Health today announced that a large clinical trial of mechanical ventilator use for intensive care patients with Acute Respiratory Distress Syndrome (ARDS) has been stopped early. The decision was recommended by the study's Data Safety and Monitoring Board (DSMB) on March 10, 1999, based on data on the first 800 patients which showed approximately 25 percent fewer deaths among patients receiving small, rather than large, breaths of air from a mechanical ventilator.
The ARDS Network Study of Ventilator Management in ARDS, scheduled to end late in 1999, was stopped early so that critical care specialists could be alerted to the results.
According to NHLBI Director Dr. Claude Lenfant, "This is the first large clinical trial to demonstrate a more effective treatment for ARDS patients. The findings will improve the care of these patients and save thousands of lives each year."
ARDS is a devastating, often fatal, inflammatory lung condition that usually occurs in conjunction with catastrophic medical conditions, such as pneumonia, shock, sepsis, and trauma. Approximately 150,000 Americans are affected each year, and more than 40 percent die.
No specific therapies currently exist for these patients. Treatment involves supportive care in an intensive care unit (ICU), including use of a mechanical ventilator and supplemental oxygen to help patients breathe.
The ARDS study was designed to compare the safety and efficacy of two different methods of setting the ventilator. After informed consent was obtained, patients were randomly assigned to receive either relatively large (12 ml/kg) or small (6 ml/kg) breaths of air from the ventilator. The initial plan for the study, which began in 1996, was to enroll 1,000 patients, ages 18 and older.
Mechanical ventilators deliver breaths of oxygen-enriched air to the
Contact: Ellen Sommer
NIH/National Heart, Lung, and Blood Institute