Continuous monitoring of respiratory function after non-cardiac surgery
Linshom Continuous Predictive Respiratory Monitor (CPRM) for Prediction of Patient Respiratory Decline
This study is testing a new device that continuously monitors breathing in patients after non-cardiac surgery to see if it can help prevent respiratory problems better than standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Linshom Medical, Inc. Industry-sponsored |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06744790 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 pulse oximetry 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, including respiratory rate and tidal volume. The study aims to compare the effectiveness of this new monitoring technology against standard care practices to better predict and manage respiratory complications post-surgery.
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 those requiring invasive ventilatory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the early detection and management of respiratory complications in post-operative patients.
How similar studies have performed: Previous studies have shown promise in using continuous monitoring technologies for respiratory management, making this approach both innovative and supported by existing research.
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
Baltimore, Maryland
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Samuel M Galvagno, DO, PhD, MS, MBA, FCCM — University of Maryland, Baltimore
- Study coordinator: James R Hughen, MBA
- Email: rhughen@linshomforlife.com
- Phone: 443-994-1448
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.