The COSMOS Trial. A Pilot Study A Pilot Study

NCT05280574 | Completed Results DMC

• 1 other identifier: 21-970
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Phase 2 - Alerts Deemed Meaningful

  During postoperative 72 hours

• Phase 2 - Clinical Interventions to Meaningful Alarms

  During postoperative 72 hours

Study Arms (3)

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

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

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

Interventions

Blinded GE Portrait Monitoring DEVICE

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

Phase 1 - prospective observational cohort study: Blinded GE Portrait monitoring; Phase 2- randomized trial: Blinded GE Portrait monitoring

Unblinded GE Portrait Monitoring DEVICE

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

Phase 2- randomized trial: Unblinded GE Portrait monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• 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. Corrigendum to 'Continuous Vital Sign Monitoring on Surgical Wards: The COSMOS Pilot. J Clin Anesth. 2026 Jan;108:111878. doi: 10.1016/j.jclinane.2025.111878. Epub 2025 Oct 30.

  PMID: 41168018 DERIVED

• 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.

  PMID: 39531997 DERIVED

Results Point of Contact

• Title: Daniel I. Sessler MD, Professor and Michael Cudahy Chair
• Organization: Outcomes Research Consortium, Department of Anesthesiology, Cleveland Clinic, Cleveland, Ohio

DS@OR.org

216-870-2620

Study Officials

• Daniel Sessler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 15, 2022
• Study Start: August 10, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-01

Locations

US (1)