First in-human trial of Miniature in-line pressure cycled, emergency respirator device at the end of scheduled surgical procedure

Clinical Center

Investigators

Abstract

Advancements in fluidic design and 3D printing have allowed the creation of a miniature, pressure-cycled automated ventilator driven by a constant input oxygen flow rate. The investigational ventilator is designed for use in adults and is simple to operate, has no moving parts, and is small enough for direct attachment to the endotracheal tube. We are now working on translating its use for humans. Preclinical work included several animal models and in vitro studies using a lung simulator. Our present translational effort will involve an evaluation in organ donors. The objective of the study is to obtain first-in-human data needed to support larger studies in more diverse human patient populations.