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Lower Tidal Volume Trial

Submitted by Nancy Ringwood on Mon, 2011-06-06 13:31

The ARMA study was a randomized, controlled multi-center 2 x 2 factorial study consisting of a drug treatment (Ketoconazole vs. placebo) and a ventilation strategy (6ml/kg tidal volume vs. 12ml/kg tidal volume).

Lower Tidal Volume Trial

The ARMA study was a randomized, controlled multi-center 2 x 2 factorial study consisting of a drug treatment (Ketoconazole vs. placebo) and a ventilation strategy (6ml/kg tidal volume vs. 12ml/kg tidal volume).

The ventilator arm of the protocol was designed to compare different ventilator strategies and their effect on mortality and morbidity. The lower tidal volume strategy (6 ml/kg) improved survival and the study was stopped early. The drug arm of the protocol, Ketoconazole did not show promise and was subsequently stopped.

ARMA Study Synopsis

Prospective, Randomized, Multi-Center Trial of 12ml/kg Tidal Volume Positive Pressure Ventilation for Treatment of Acute Lung Injury and Acute Respiratory Distress Syndrome (ARMA)

This landmark third trial examined lower tidal volume ventilation versus a traditionally recommended larger tidal volume approach in patients with acute lung injury . This trial was undertaken because extensive animal studies and two small clinical trials suggested lung stretch with larger tidal volumes may injure the lung or prevent recovery. However, two other clinical trials raised questions about this hypothesis and the use of smaller tidal volumes is not always easy to do.