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

NCT ID: NCT06133140

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 227 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2026-01-06

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.

Detailed Description

Primary Aim. 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.

Primary hypothesis. Unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized.

Secondary Aim. Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions.

Secondary hypothesis. Unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, and bradycardia within 48 hours after major non-cardiac surgery.

Conditions

Postoperative Complications

Study Design

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

Study Groups

Blinded monitoring

Continuous postoperative vital sign monitoring blinded to clinicians and investigators.

Blinded postoperative vital sign monitoring

Intervention Type: DEVICE

Blinded postoperative GE Portrait monitoring

Unblinded monitoring

Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.

Unblinded postoperative vital sign monitoring

Intervention Type: DEVICE

Unblinded postoperative GE Portrait monitoring

Interventions

Unblinded postoperative vital sign monitoring

Unblinded postoperative GE Portrait monitoring

Intervention Type: DEVICE

Blinded postoperative vital sign monitoring

Blinded postoperative GE Portrait monitoring

Intervention Type: DEVICE

Other Intervention Names

Unblinded group; Blinded group

Eligibility Criteria

Inclusion Criteria

1. Are expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution;

2. Are ≥18 years old;

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

4. Are scheduled for major noncardiac surgery lasting at least 1.5 hours;

5. Are expected to remain hospitalized at least one postoperative night;

6. Are expected to have general or neuraxial anesthesia.

Exclusion Criteria

1. Have language, vision, or hearing impairments that might compromise continuous monitoring;

2. Are designated Do Not Resuscitate, hospice, or receiving end of life care;

3. Are expected to have telemetry monitoring;

4. 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

Ryu Komatsu, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

24-009

Identifier Type: -

Identifier Source: org_study_id