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

Launched by LINSHOM MEDICAL, INC. · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Linshom Continuous Predictive Respiratory Sensor, which aims to improve the monitoring of patients after non-cardiac surgery. The goal is to better predict and prevent respiratory problems, like low oxygen levels, in patients who are recovering in the Post Anesthesia Care Unit (PACU). The researchers will enroll 320 patients who are at least 18 years old, have had surgery, and are expected to stay in the hospital overnight while receiving supplemental oxygen through a face mask.

Participants in this trial can expect to wear an oxygen mask fitted with the Linshom sensor, which will continuously collect information about their breathing and oxygen levels without interfering with their care. The medical staff will monitor the patients as usual, and any changes in their condition will be recorded to help improve patient safety during recovery. It’s important to note that patients who need special breathing support or are having outpatient surgery will not be eligible for this study. This research may lead to better ways to keep patients safe after surgery by providing more accurate monitoring of their respiratory health.

Gender

ALL

Eligibility criteria

• 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