The COSMOS Trial. A Pilot Study A Pilot Study

Last updated: January 31, 2025
Sponsor: The Cleveland Clinic
Overall Status: Completed

Phase

N/A

Condition

Surgery

Treatment

Blinded GE Portrait Monitoring

GE Portrait Monitoring with intervened by clinician

Unblinded GE Portrait Monitoring

Clinical Study ID

NCT05280574
21-970
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are admitted to one of the wards equipped with the GE Portrait Mobile Solution.

  • Are designated American Society of Anesthesiologists physical status 1-4.

  • Had major noncardiac surgery lasting at least 1.5 hours.

  • Are expected to remain hospitalized at least two postoperative nights.

  • Had general anesthesia with or without neuraxial anesthesia.

Exclusion

Exclusion Criteria:

  • Have language, vision, or hearing impairments that may compromise continuousmonitoring.

  • Are designated Do Not Resuscitate, hospice, or receiving end of life care

  • Have previously participated in the study.

Study Design

Total Participants: 250
Treatment Group(s): 5
Primary Treatment: Blinded GE Portrait Monitoring
Phase:
Study Start date:
August 10, 2022
Estimated Completion Date:
August 30, 2023

Study 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.

Connect with a study center

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

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