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

NCT06133140 | Completed DMC

• 1 other identifier: 24-009
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.

Conditions

Postoperative Complications

Keywords

Postoperative; Anesthesia; Vital signs

Outcome Measures

Primary Outcomes (3)

• Hypoxemia

  Area of oxygen saturation defined as SpO2 ≤85%.

  48 postoperative hours.

• Inadequate or excessive ventilation

  Area of inadequate or excessive ventilation defined as respiratory rate ≤4/min or ≥30/min.

  48 postoperative hours.

• Bradycardia and tachycardia

  Area of inadequate or excessive heart rate defined as ≤40/min or ≥130/min.

  48 postoperative hours.

Secondary Outcomes (1)

• The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.

  48 postoperative hours.

Study Arms (2)

Blinded monitoring

Continuous postoperative vital sign monitoring blinded to clinicians and investigators.

Device: Blinded postoperative vital sign monitoring

Unblinded monitoring

Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.

Device: Unblinded postoperative vital sign monitoring

Interventions

Blinded postoperative vital sign monitoring DEVICE

Blinded postoperative GE Portrait monitoring

Also known as: Blinded group

Blinded monitoring

Unblinded postoperative vital sign monitoring DEVICE

Unblinded postoperative GE Portrait monitoring

Also known as: Unblinded group

Unblinded 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 expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution;
• Are ≥18 years old;
• Are designated American Society of Anesthesiologists physical status 1-4;
• Are scheduled for major noncardiac surgery lasting at least 1.5 hours;
• Are expected to remain hospitalized at least one postoperative night;
• Are expected to have general or neuraxial anesthesia.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryu Komatsu, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 15, 2023
• Study Start: February 14, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 6, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after publication of main paper.
• Access Criteria: Contact PI.

Locations

US (1)