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) forrespiratory monitoring are responsive by sounding a warning alarm when a patient reaches a threshold of aphysiologic parameter (i.e. SpO2, ETCO2) and the patient is currently or has been in distress. Technologicallimitations have prevented the field from moving further in its ability to predict patient decline so that healthcare providers (HCPs) are able to intervene and stop or correct respiratory decline. Linshom has developed asimple, 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) solvesexisting unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracksRR, TV, MV, seconds since last breath (SSLB), and I:E ratio in real time. These parameters are crucial formonitoring of patients suffering from both acute and chronic respiratory illness. Unlike other respiratorymonitoring 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 withappropriate medical care. Timely intervention should reduce morbidity and mortality and result in significantlyimproved care for the patient and large savings for the health care system via reduction in rapid responseactivation and ICU transfers. Linshom's unique ability to provide TV (and thus MV) in the non-intubated patientcreates a profile of patient respiratory status previously not available outside of the OR or ICU (and only inintubated patients).In this Fasttrack SBIR we will i) Generate clinical data proving Linshom CPRM's ability to detect (predict) arespiratory depression episode (RDE) before current standard of care and devices, ii.) Determine optimal timesto set early warning alarms (maximizing sensitivity and specificity) such that HCPs can intervene sooner thancurrent practice and avoid morbidity and mortality due to respiratory failure, and iv.) Redesign the CPRS into aminiaturized chip based device enabling the Linshom CPRM to reach more patients by enabling nasal cannula(and eventually a home monitor) integration.
Public Health Relevance Statement: Project Narrative This SBIR research will demonstrate a superior method of respiratory monitoring that will be first to enable continuous predictive respiratory monitoring (CPRM) at the patient bedside and in the future at the patient's home. This research (phase 1 and 2) and innovative product research & development (phase 2) will enable commercialization of the Linshom CPRM that will move the entire field of respiratory monitoring from responsive (too late) to predictive, where patient respiratory decline is identified when health care providers can take action and pre-empt patient decline. This will reduce morbidity, mortality and healthcare expense. The engineering research (phase 2) will re-design and miniaturize the sensor technology allowing these developments to be embedded in multiple additional, smaller form factors (i.e. nasal cannula, home use) to reach more patients in need of continuous, predictive respiratory monitoring.
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