Creating an in vivo hypoxic environment by gas inhalation for the potential evaluation of new pulse oximeters

Abstract

Pulse oximetry is a noninvasive technique for the continuous monitoring of arterial oxygen saturation using an oximeter, a standard medical device used for assessing respiratory function. The development of pulse oximeters for the production of generic medical devices is expected to continue. Clinical trials to evaluate oxygen saturation measurements are necessary for the manufacture and commercialization of pulse oximeters. However, no standardized guidelines or methodologies exist for conducting such clinical trials. Therefore, we exploratively aimed to create a hypoxic state in humans to conduct a clinical trial for generic pulse oximeters using a gas-mixing device.