Monitoring vital signs in patients recovering from major surgery
Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial
This study tests if using a new mobile monitoring system can help patients recovering from major surgery by keeping a close eye on their vital signs to improve their recovery and reduce complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 856 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06133140 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of continuous ward monitoring using the GE Portrait Mobile Monitoring Solution in reducing vital sign abnormalities in patients recovering from major noncardiac surgery. The primary focus is on whether unblinded monitoring and nursing alerts can improve patient outcomes during the first 48 hours post-surgery. Additionally, the study will assess the impact of continuous monitoring on the need for respiratory and cardiovascular interventions. Participants will be monitored for vital signs such as saturation, ventilation, and pulse rate.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for major noncardiac surgery lasting at least 1.5 hours and expected to stay hospitalized for at least one night.
Not a fit: Patients who are designated Do Not Resuscitate, receiving end-of-life care, or have impairments that could affect monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved postoperative care and reduced complications for patients recovering from major surgery.
How similar studies have performed: Other studies have shown promise in using continuous monitoring technologies to enhance patient safety and outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Are expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution; 2. Are ≥18 years old; 3. Are designated American Society of Anesthesiologists physical status 1-4; 4. Are scheduled for major noncardiac surgery lasting at least 1.5 hours; 5. Are expected to remain hospitalized at least one postoperative night; 6. Are expected to have general or neuraxial anesthesia. Exclusion Criteria: 1. Have language, vision, or hearing impairments that might compromise continuous monitoring; 2. Are designated Do Not Resuscitate, hospice, or receiving end of life care; 3. Are expected to have telemetry monitoring; 4. Have previously participated in the study.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Daniel I Sessler, MD — The Cleveland Clinic
- Study coordinator: Daniel I Sessler, MD
- Email: sessled@ccf.org
- Phone: 216-445-6500
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.