Federal Project Grant Award Summary

The National Heart, Lung, and Blood Institute (NHLBI) awarded a $753,721 Project Grant to The Johns Hopkins University (Award Date: May 1, 2026; Completion Date: January 31, 2031) under the Cardiovascular Diseases Research program (CFDA 93.837) to conduct the ENHANCE-O2 study. This research initiative investigates pulse oximeter accuracy and clinical outcomes in hospitalized patients with shock and acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The project addresses a critical gap identified by the investigators regarding pulse oximeter testing, which is currently required only on healthy volunteers in laboratory settings for FDA clearance, despite evidence that these devices overestimate oxygen saturation in critically ill patients—particularly those with darker skin pigmentation—resulting in delayed clinical interventions and poor outcomes.

The Johns Hopkins team will conduct a large-scale retrospective cohort analysis using a unique high-frequency repository of vital sign and waveform data to precisely compare concurrent pulse oximeter readings (SpO2) against gold-standard arterial oxygen saturation measurements (SaO2) in patients with severe physiologic derangements that cannot be simulated in laboratory settings. The study will characterize shock based on vasopressor requirements or low cardiac output and apply FDA-cleared algorithms to stored arterial catheter waveforms to determine cardiac output. This clinical research will generate evidence-based data on pulse oximeter performance in acutely ill patient populations, directly informing FDA regulatory requirements and advancing the accuracy and equity of non-invasive oxygenation monitoring in clinical practice.