NCT05280574

The COSMOS Trial. A Pilot Study A Pilot Study

Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial A Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. Data obtained in the proposed pilot cohort will guide design of a future robust randomized trial comparing clinical interventions and serious complications with blinded versus unblinded continuous ward monitoring.

Detailed description

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. The system is a novel battery-powered untethered monitor for continuous monitoring of oxygen saturation, respiratory rate, and pulse rate that is designed for use by patients on surgical wards. The initial phase will evaluate patient tolerance, with clinicians and patients blinded to monitor data. Results will be used to evaluate the frequency of respiratory events and pulse rate abnormalities. These data will be used to design clinical alert settings, based on various durations at various thresholds (e.g., saturation \<85% for \>1 minute). Our main goal will be to identify clinically meaningful vital sign abnormalities with a minimum of false alerts. Secondarily, the investigators will evaluate the frequency and duration of abnormalities, and the fraction that are detected clinically. In the second phase of the pilot, clinicians will be unblinded to the GE Portrait monitors, and alerts provided based on the durations and threshold identified in the initial part of the pilot. The primary outcomes will be clinician tolerance and the extent to which clinicians believe that vital sign trending and alerts provided useful information rather than distraction. Specifically, the investigators will assess the fraction of alerts that clinicians deemed meaningful, and the fraction that resulted in clinical interventions. In the third phase of the pilot, the durations and thresholds for saturation, respiratory rate, and pulse rate that trigger alerts will be adjusted based on results from the second phase.

Conditions

• Surgery

Interventions

Type	Name	Description
DEVICE	Blinded GE Portrait Monitoring	Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.
DEVICE	Unblinded GE Portrait Monitoring	Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.

Timeline

• Start date: 2022-08-10
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-03-15
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

1 site across 1 country: United States