Monitoring respiratory health after non-cardiac surgery with a new sensor
Advanced Prediction of Respiratory Depression Episode With the Linshom Continuous Predictive Respiratory Sensor
This study is testing a new breathing monitor for patients recovering from non-cardiac surgery to see if it can better track their respiratory health compared to standard monitoring methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Linshom Medical, Inc. Industry-sponsored |
| Locations | 2 sites (Ellicott City, Maryland and 1 other locations) |
| Trial ID | NCT05804175 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll 320 patients undergoing non-cardiac surgery who will receive supplemental oxygen and continuous monitoring in the Post Anesthesia Care Unit (PACU). Participants will be fitted with a Linshom Continuous Predictive Respiratory Monitor, which tracks critical respiratory indicators in real-time. The study aims to compare the effectiveness of this new monitoring technology against standard care practices, including pulse oximetry and capnography. Data collected will help identify respiratory decline early, allowing for timely medical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing non-cardiac surgery who will be admitted to the PACU and require supplemental oxygen.
Not a fit: Patients who are undergoing outpatient surgery or require invasive ventilatory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the monitoring and management of respiratory complications in post-surgical patients.
How similar studies have performed: Previous studies have shown promise in using advanced monitoring technologies for respiratory management, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ellicott City, Maryland and 1 other locations
- Linshom Medical, Inc. — Ellicott City, Maryland, United States (Recruiting)
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.