Advanced Prediction of Emerging Respiratory Decline with the Linshom Continuous Predictive Respiratory Sensor (CPRS)

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Abstract: This Fast-track SBIR application will fund and enable a new approach to respiratory monitoring, continuous predictive respiratory monitoring (CPRM), that stands 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 510k 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 Fasttrack SBIR we will i) Generate clinical data proving Linshom CPRM’s ability to detect (predict) a respiratory depression episode (RDE) before current standard of care and devices, ii.) Determine optimal times to set early warning alarms (maximizing sensitivity and specificity) such that HCPs can intervene sooner than current practice and avoid morbidity and mortality due to respiratory failure, and iv.) Redesign the CPRS into a miniaturized chip based device enabling the Linshom CPRM to reach more patients by enabling nasal cannula (and eventually a home monitor) integration.