DIGITAL INCENTIVE SPIROMETRY EXERCISER TO IMPROVE PATIENT ADHERENCE AND CLINICAL WORKFLOWS

Lung complications occur in 1 in 20 people that receive a surgery that requires an overnight stay in the hospital, even if their surgery is not near the lungs. Anesthesia during surgery and inactivity during recovery cause air sacs in the lungs to deflate, which puts patients at risk of complications like pneumonia that increase mortality five-fold, increase lengths of stay and recovery periods, and are both costly and non-reimbursable. The current standard of care is to prevent lung complications with use of incentive, or therapeutic, spirometry, where patients must breathe in from an incentive spirometer device 10x each hour to inflate their alveoli. Proper incentive spirometry can prevent 1 in 3 post-surgery lung complications. However, current incentive spirometers are entirely mechanical, making it difficult for nurses to track patient adherence to their exercises beyond labor-intensive bedside monitoring. The majority of incentive spirometry is currently self-monitored and self-reported by patients, which leads to poor adherence and overreporting. This makes incentive spirometry largely inefficient and ineffective in the clinic today. Airalux seeks to solve this problem with a redesigned incentive spirometer that can automatically collect user metrics and display them on a mobile dashboard for clinician monitoring. The Airalux device is also designed to increase incentive spirometry adherence through behavioral nudges and goal setting for patients. We have developed a unique combination of sensors, mechanical design, and a software suite that can directly measure patient airflow and does not rely on the mechanical piston systems of current incentive spirometers, which are clunky, difficult to digitize, and introduce large opportunities for user error. The goal of this technology is to make incentive spirometry easy for patients to use and easy for clinicians to monitor. The aims of this project are to develop a prototype with reduced materials costs that make it viable and affordable for clinical use. Because this technology relies on environmentally sensitive sensor configurations, we must also verify that our reduced-cost device can measure inhalation volumes accurately in a broader range of environmental settings. This will enable advancement of our technology to Phase II, when we will conduct a randomized clinical trial with patients using our lower cost prototype and assess clinical outcomes from increased adherence, such as improved oxygenation and reduced complication rates. Commercially, this device seeks to improve patient outcomes after surgery, while also saving hospitals non-reimbursable costs associated with lung complication treatment and readmissions. Project Number: 1R43HL180242-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Yi-An Hsieh | Institution: AIRALUX MEDICAL, INC., PHILADELPHIA, PA | Award Amount: $306,872 | Activity Code: R43 | Study Section: Special Emphasis Panel[ZHL1 CSR-D (M1)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R43HL18024201A1