The COSMOS Trial. A Pilot Study A Pilot Study

NCT ID: NCT05280574

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-08-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Phase 1 - prospective observational cohort study: Blinded GE Portrait monitoring

Patients in phase 1 will receive continuous vital sign monitoring blinded to patients and clinicians.

Blinded GE Portrait Monitoring

Intervention Type: DEVICE

Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.

Phase 2- randomized trial: Blinded GE Portrait monitoring

Continuous vital signs will be monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead will rely on routine vital sign assessments at 4-hour intervals.

Blinded GE Portrait Monitoring

Intervention Type: DEVICE

Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.

Phase 2- randomized trial: Unblinded GE Portrait monitoring

Physician investigators will monitor and evaluate continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring. Patients who are randomized to the unblinded GE Portrait monitoring might be intervened if the clinicians believe that the alarm is clinically meaningful.

Unblinded GE Portrait Monitoring

Intervention Type: DEVICE

Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.

Interventions

Blinded GE Portrait Monitoring

Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.

Intervention Type: DEVICE

Unblinded GE Portrait Monitoring

Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.

Intervention Type: DEVICE

Eligibility Criteria

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 Criteria

• Have language, vision, or hearing impairments that may compromise continuous monitoring.
• Are designated Do Not Resuscitate, hospice, or receiving end of life care
• Have previously participated in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Sessler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Anusic N, Gulluoglu A, Ekrami E, Mascha EJ, Li S, Coffeng R, Turan A, Clemens A, Perez C, Beard JW, Sessler DI; COSMOS Pilot Investigators. Continuous vital sign monitoring on surgical wards: The COSMOS pilot. J Clin Anesth. 2024 Dec;99:111661. doi: 10.1016/j.jclinane.2024.111661. Epub 2024 Nov 11.

Reference Type: DERIVED

PMID: 39531997 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

21-970

Identifier Type: -

Identifier Source: org_study_id