Investigators will enroll 493 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask or nasal cannula, and will be on continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). Research personnel will screen and select subjects for this study. The CRA will ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival at the PACU, each subject will be fitted with a supplemental oxygen mask or nasal cannula containing the Linshom sensor, which will be connected to Linshom Cyber G-15 monitor for data collection. A pulse oximeter will be applied to the hand (non-NIBP arm), which will be connected to a hospital monitor (SOC). The Linshom G-15 monitor will collect data every 100 milliseconds. The Linshom CPRM will automatically initiate baseline data capture. The CRA will begin recording any clinical interventions (e.g., medications and stimulation upon detection of changes in patient's condition) that are performed by the PACU staff, paying close attention to time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. After data collection, the Linshom engineers will retrieve the data from all monitors and time-sync all data collected from each patient (Linshom CPRM and pulse oximetry). Manually recorded data regarding the time points at which clinical interventions were provided by the PACU staff will also be reviewed and those time points will be noted as RDEs.
The Linshom CPRM system monitors the distinct metric of RDE occurrence. Throughout a given patient's stay, nurses will be provided with two distinct cues (each cue comprised of an auditory and visual component), 1 from CPRM, 1 from SoC, alerting them to a patient's respiratory state. In addition, clinical staff will have access to a summary metrics of critical parameters and RDE occurrences on the Linshom monitor (total RDE count, time since last RDE).
At least 18 years of age undergoing non-cardiac surgery
Post-operative patients admitted to the post-anesthesia care unit (PACU) and expected to stay in the hospital for at least overnight.
Receiving supplemental oxygen via face mask or nasal cannula in the PACU
On continuous SpO2 saturation monitoring
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
Single group
Linshom Continuous Predictive Respiratory Monitoring
DeviceLinshom CPRM with alarms enabled will be used to alert nurses of respiratory issues. Action will be taken based on nurse assessment and will follow standard of care procedures.
Measure the number of Respiratory Depression Events (RDE) of Linshom CPRM + standard of care (SOC) vs. SOC alone.
Demonstrate that the CPRM system can reduce the frequency of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff. The statistical test to be used is a negative binomial regression model, which is appropriate for modeling count data (RDE rates) with potential overdispersion.
Measure the length (in seconds) of RDE per patient with Linshom CPRM + standard of care (SOC) vs. SOC alone.
Demonstrate that the CPRM system can reduce the length of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff. The statistical tests will evaluate: Mean/Median Time Per RDE.
Measure the Mean/Median Cumulative RDE Time Per Patient in Linshom + SOC vs. SOC alone.
Demonstrate that Linshom Medical + SOC can reduce the Mean/Median Cumulative RDE Time Per Patient vs. SOC alone.
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Linshom Medical, Inc.
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Ohio State University
Collaborator
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