NCT Number: NCT07793981
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Linshom Medical, Inc., Baltimore, Maryland, United States
Linshom has developed the Continuous Predictive Respiratory Monitoring (CPRM) system, designed to alert clinicians of active or impending respiratory distress events. The system features a miniaturized version of the FDA cleared Linshom Continuous Predictive Respiratory Sensor - a small, wearable sensor that provides continuous real-time tracking of the critical indicators of RDE. 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. The technology is based on a novel thermal sensor which is regulated by a thermo-electric cooler utilizing a proprietary control loop process. Respiration state is measured via temperature change throughout a patients inspiratory/expiratory cycle. This delivers a respiratory signature allowing for continuous measurement of RR, rTV, rMV, SSLB, apnea detection, and I/E ratio. The CPRM system solves the unmet need for a small, portable, sensor and monitor that tracks RR, rTV, rMV, 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.
The main focus will be performing an unblinded trial where the CPRM system is actively used to guide clinical intervention with the aim of reducing burden of RDEs, which will provide critical evidence of the clinical care and health economic cost benefits of the CPRM system.
Specific aim:
Conduct an unblinded clinical trial to demonstrate that Linshom CPRM + standard of care (SOC) can reduce Respiratory Depression Episodes by at least 30% compared to SOC alone.
Outcome: Demonstrate that the CPRM system can reduce the frequency and 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Linshom 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.
Other names: Pulse Oximetry
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months.
Demonstrate that Linshom Medical + SOC can reduce the Mean/Median Cumulative RDE Time Per Patient vs. SOC alone.
Contact information is provided by the study sponsor or research team.
James R Hughen, MBA
CONTACT
Ronen Feldman, BS
CONTACT
Linshom Medical, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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