Abstract #302381

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JSM 2003 Abstract #302381
Activity Number: 64
Type: Invited
Date/Time: Sunday, August 3, 2003 : 6:00 PM to 8:00 PM
Sponsor: Biometrics Section
Abstract - #302381
Title: The ARDSnet Controversy: What Is the Best Trial Design to Develop Evidence-Based Mechanical Ventilation?
Author(s): David A. Schoenfeld*+
Companies: Massachusetts General Hospital
Address: 50 Staniford Street, Boston, MA, 02114-2517,
Keywords:
Abstract:

In 1994 the National Heart Lung and Blood Institute formed the ARDS clinical network, whose purpose was to plan and conduct clinical trials of Acute Respiratory Distress Syndrome, a condition that affects nearly 50,000 Americans a year, with a fatality rate of 30-50%. The network decided that its first trial study was to determine how best to control the tidal volume (breath size) delivered during mechanical ventilation. Traditionally, high tidal volumes were used to ensure patient comfort, maintain acid-base balance by more effectively removing carbon dioxide, and to improve oxygination. However, animal studies and one small single-institution clinical trial indicated that lower tidal volumes might improve mortality.

In 1994 there was a wide range of practice. The network trial was designed to compare two tidal volumes; 12 mg/kg which was considered in the middle of the "traditional" range and was at the 80th percentile of the tidal volumes that patients were on before they started the study, and 6 mg/kg which was the tidal volume suggested by the single center trial. The trial, which finished in 2000, showed a decrease in mortality from 40% to 30% in the low tidal volume group

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