New ventilator modes: the shape of things to come?

نویسنده

Richard D Branson

چکیده

The complexities of mechanical ventilators have been chronicled in these pages over the last few decades as investigators and manufacturers have searched for improved outcomes and competitive advantage. On several occasions I have had the privilege of writing about the current state of the art and the promise of closed-loop mechanical ventilation.1–3 While new modes of mechanical ventilation have failed to impact outcomes, the innovation and invention continue. The promises of closed-loop ventilation include improved safety, improved patient comfort, and rapid response to change in patient condition. Survival outcomes are elusive and expensive. Under the current regulatory framework, the funds necessary to undertake a study capable of determining the effects of a new mode on outcome are not available. Manufacturers need only to demonstrate engineering success in a lung model in order to obtain marketing approval through the Food and Drug Administration’s 510(k) process; patient studies are not required. This leaves the clinician in a bit of a quandary. That is, unlike drugs, which have to prove superiority or noninferiority prior to marketing, new ventilation modes are available to the masses prior to any breadth of knowledge regarding application and safety. In essence, each new use is like a clinical research project with an n of 1 and no protocol or informed consent. To complicate matters, much of the education regarding new modes originates with the manufacturer. I have great admiration and respect for many of our colleagues in industry, but we rely too much on their educational initiatives, which drive new technology based on improved sales, not improved outcomes.

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