RecruitingNCT06744790

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

Linshom Continuous Predictive Respiratory Monitor (CPRM) for Prediction of Patient Respiratory Decline


Sponsor

Linshom Medical, Inc.

Enrollment

320 participants

Start Date

Jun 21, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Investigators will enroll 320 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask, and will be on a continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). The enrollment criteria were adapted from a previous study that showed SpO2 values seriously underestimated the severity of post-operative hypoxemia in patients with and without specific risk factors for hypoxemia. Research personnel will screen and ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival to the PACU, each subject will be fitted with oxygen mask containing the Linshom sensor, which will be connected to a Linshom monitor for data collection. A side stream capnography line will be connected to the same face mask and the capnography data will be collected on the Zoe Medical 740 SELECT™ monitor. Additionally, two pulse oximeters will be applied to the same hand (non- NIBP arm), one of which will be connected to a hospital monitor (SoC) and the other to a Zoe Medical 740 SELECT™ monitor. The Linshom and 740 SELECT™ monitors will collect data once every second. Research personnel will then initiate the Linshom CPRM baseline mode and begin recording any clinical intervention (e.g., medications, oxygen delivery change, and stimulation upon detection of changes in patient's condition) that is performed by the PACU staff, paying close attention to, and recording of time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. The CPRM data collection will be performed passively while the patient is monitored via SoC and will not interfere with clinical interventions that may take place during the data collection. Clinical staff in the PACU will be blinded to the Linshom CPRM data as well as pulse oximetry (non-SOC monitor) and capnography data collected.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a wearable sensor (the Linshom device, worn on the chest) can predict when a patient recovering from surgery might stop breathing adequately — a dangerous complication called respiratory depression — allowing nurses to intervene earlier. **You may be eligible if...** - You are 18 or older - You are recovering from non-cardiac surgery in the post-anesthesia care unit (recovery room) - You are expected to stay in the hospital at least overnight - You are receiving supplemental oxygen through a face mask - You are already on continuous oxygen monitoring **You may NOT be eligible if...** - You require a ventilator or invasive breathing support after surgery - You only received local or topical anesthesia (no general or IV sedation) - You are having same-day outpatient surgery - You are unable to cooperate with having the device attached Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICELinshom Continuous Predictive Respiratory Monitoring

Observational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care.


Locations(1)

University of Maryland Medical Center

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06744790


Related Trials