Cost-benefit considerations in managing oxygenation failure.

The evaluation of new therapy poses a formidable challenge in intensive care medicine. When therapy evaluation cannot be double-blinded, as in the evaluation of extracorporeal support, the problem becomes more difficult. The result of the extracorporeal clinical trial, like that of the ECMO trial in the 1970s, is a potent reminder of the importance of concurrent controls in such evaluations. We should view with caution ethical objections to controlled trials of therapies that are not supported by credible data. A stronger ethical argument may frequently be mounted in favor of a randomized, controlled clinical trial. This is particularly pertinent in the high-technology ICU environment in which information overload is intense. The establishment of ICU human laboratories should enable the medical community to make much needed progress and help us identify the useful elements in our therapeutic armamentarium.