Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor

Linshom Medical (Linshom) has developed the FDA-cleared Continuous Predictive Respiratory Monitor (CPRM) a small and inexpensive sensor and monitor that provides continuous real-time tracking of these critical indicators of RDE. Linshom technology is based on our novel Linshom thermal sensor which is regulated by a thermoelectric cooler utilizing a proprietary control loop process. Respiration state is measured via temperature change throughout a patient's inspiratory/expiratory cycle. This delivers a respiratory signature allowing for continuous measurement of RR, relative Tidal Volume (rTV), relative Minute Ventilation (rMV), seconds since last breath (SSLB), and inspiratoryexpiratory (I/E) ratio. The CPRM solves existing unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracks RR, rTV, rMV (calculation of RR x rTV), seconds since last breath (SSLB), and I:E ratio in real time and continuously. These parameters are crucial in monitoring of patients suffering from both acute and chronic respiratory illness. Linshom offers an OR-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care.

In Phase I, investigators will conduct a clinical study in 145 post-operative patients comparing Linshom's CPRM to current SOC (clinical attention + pulse oximetry) and capnography. We will collect SOC, CPRM and capnography data simultaneously from each patient to demonstrate the ability of Linshom CPRM to identify Respiratory Depression Episodes in advance of SOC and/or capnography.

In Phase II, investigators will conduct a continuation of the phase I clinical study until the enrollment for this phase (175 patients) is reached, which would give an adequate statistical power for development of the Linshom CPRM alarm function.

Specific aims:

Aim 1: Demonstrate that Linshom CPRM is able to identify RDE earlier than pulse oximetry and capnography.

o Outcome: Investigators expect to successfully demonstrate that Linshom CPRM is capable of identifying RDE in advance of pulse oximetry and capnography by performing statistical analyses (non-inferiority and superiority hypothesis tests).

Aim 2: Identify parameters and threshold values for the alarm function of Linshom CPRM for RR, rTV percent change, rMV percent change, I:E ratio and SSLB.

Outcome: Investigators will identify Linshom CPRM parameters and threshold values with high predictive abilities for RDE. These parameters and threshold values will be incorporated into future product to alert for clinicians and allow them to provide timely interventions to patients.

Inclusion criteria

• ≥18 years old undergoing non-cardiac surgery
• Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight
• Receiving supplemental oxygen via face mask in the PACU
• On continuous SpO2 saturation monitoring
• Receiving standard postoperative of care

Exclusion criteria

• Requirement for any form of postoperative invasive ventilatory support
• Patients receiving only local or topical anesthesia
• Day/outpatient surgery
• Unable to cooperate with the application of the study device
• Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation