Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline with the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)

This CRP proposal will fund clinical development activities focused on demonstrating the health economic value of Linshom’s continuous predictive respiratory monitoring (CPRM) system. The CPRM system has the potential to reduce morbidity and mortality due to respiratory compromise, while reducing health care system costs. Current devices and systems (human and machine) for respiratory monitoring are responsive by sounding a warning alarm when a patient reaches a threshold of a physiologic parameter (i.e. SpO2, ETCO2) and the patient is currently or has been in distress. Technological limitations have prevented the field from moving further in its ability to predict patient decline so that health care providers (HCPs) are able to intervene and stop or correct respiratory decline. Linshom has developed a simple, inexpensive solution for continuous monitoring of respiratory functions including RR, TV, MV, I:E ratio, and apnea detection. Linshom's 510(k), FDA-cleared Continuous Predictive Respiratory Sensor (CPRS) solves existing unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracks RR, TV, MV, seconds since last breath (SSLB), and I:E ratio in real time. These parameters are crucial for monitoring of patients suffering from both acute and chronic respiratory illness. Unlike other respiratory monitoring technologies, Linshom offers an operating room-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care. Timely intervention should reduce morbidity and mortality and result in significantly improved care for the patient and large savings for the health care system via reduction in rapid response activation and ICU transfers. Linshom’s unique ability to provide TV (and thus MV) in the non-intubated patient creates a profile of patient respiratory status previously not available outside of the OR or ICU (and only in intubated patients). In this CRP proposal we will generate clinical data proving Linshom CPRM’s ability to reduce the frequency and length of respiratory depression episodes (RDE) more effectively than SoC alone in post anesthesia care units (PACU). We expect the results of this trial to demonstrate the effectiveness of the CPRM system in providing measurable benefit to hospital systems by reducing the burden of respiratory distress in the PACU. Project Number: 1SB1HL182474-01 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Ronen Feldman | Institution: LINSHOM MEDICAL INC, ELLICOTT CITY, MD | Award Amount: $322,277 | Activity Code: SB1 | Study Section: Special Emphasis Panel[ZHL1 CSR-D (M1)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1SB1HL18247401