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

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Blinded GE Portrait Monitoring; Device: Unblinded GE Portrait 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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who are older than 18 years of age. Patients have a ASA status 1-4. The patients whom had a major noncardiac surgery lasting at least 1.5 hours and are expected to remain hospitalized at least two postoperative nights, and are being admitted to a ward equipped with the GE Portrait Mobile Monitor.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Blinded GE Portrait Monitoring; 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.	Device: Blinded GE Portrait Monitoring; 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.	Device: Unblinded GE Portrait Monitoring; Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2- Cumulative Duration of Vital Sign Abnormalities	The vital sign abnormalities is a 5-component composite including the durations of SpO2 <85%, heart rate <45/min, heart rate >130/min, respiratory rate <4/min and respiratory rate >30/min.	Up to 72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2 - Alerts Deemed Meaningful	Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group	During postoperative 72 hours
Phase 2 - Clinical Interventions to Meaningful Alarms	Number of clinical interventions by the three categories of meaningful alarms (informative, important, and critical). An investigator will ask the relevant clinician (usually a nurse) to rate each alert as clinically meaningful or not. Specifically, clinicians will be asked to rate alerts as "critical," "important," "informative," or "false or distracting." The terms will intentionally not be further defined, thereby allowing caregivers to determine themselves the extent to which a given alert was helpful or not. Caregivers will be queried in person shortly after each alert, typically within 15 minutes. The thresholds, determined in the initial phase, will be set to generate an average of about 2 alerts per patient per day - and therefore will not be onerous for clinicians.	During postoperative 72 hours

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Daniel Sessler, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21-970

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No