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ID06744790

Study of Linshom Continuous Predictive Respiratory Monitor to Detect Respiratory Decline After Non-Cardiac Surgery in Post-Operative Patients

Led by Linshom Medical, Inc. · Updated on 2024-12-20

320

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new device called the Linshom Continuous Predictive Respiratory Monitor CPRM to improve the early detection of respiratory depression episodes RDE in patients recovering from non-cardiac surgery. This observational study involves 320 post-operative patients in the Post Anesthesia Care Unit PACU who receive supplemental oxygen and continuous monitoring. The study aims to compare the Linshom CPRMs ability to predict respiratory decline earlier than the current standard of care, including pulse oximetry and capnography. During the study, each participant will be fitted with a face mask containing the Linshom sensor connected to a monitor for continuous data collection. Additional monitoring devices include standard pulse oximeters and capnography equipment. Data will be recorded every second throughout the patients entire stay in the PACU. Clinical interventions such as medication or oxygen adjustments will be noted alongside the sensor data, but the clinical staff will not have access to the Linshom CPRM data during the study. Participants will undergo continuous respiratory monitoring while receiving standard postoperative care. Research staff will collect detailed information on respiratory parameters like respiratory rate, tidal volume, and minute ventilation using the Linshom device. The main outcome measured is the Linshom CPRMs ability to predict respiratory depression episodes earlier than pulse oximetry. Data collection will continue through the PACU stay, and the study will analyze both non-inferiority and superiority of Linshom CPRM compared to current monitoring methods over 6 to 24 months.

CONDITIONS

Brief Title

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

Research Team

J

James R Hughen, MBA

R

Ronen Feldman, BS

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