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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Device: Blinded postoperative vital sign monitoring; Device: Unblinded postoperative vital sign monitoring

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.

• Study Type: Observational
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blinded monitoring; Continuous postoperative vital sign monitoring blinded to clinicians and investigators.	Device: Blinded postoperative vital sign monitoring; Blinded postoperative GE Portrait monitoring; Other Names: Blinded group
Unblinded monitoring; Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.	Device: Unblinded postoperative vital sign monitoring; Unblinded postoperative GE Portrait monitoring; Other Names: Unblinded group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.	Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces substantive respiratory and cardiovascular interventions. Each intervention will be considered dichotomously (occurred or not), and together constitute a composite outcome: Supplemental oxygen (or substantive dose escalation as indicated by a new administration method) excluding oxygen that patients are already using when they arrive on the ward;; New-onset inhaled drugs (e.g., steroids, bronchodilators);; Naloxone or flumazenil administration;; Non-invasive ventilatory support including bag & mask ventilation, but excluding use of home CPAP and similar devices;; Bolus fluid administration (e.g., >500 ml);; Drug treatments for bradycardia (e.g., new onset atropine or glycopyrrolate) and discontinuing drugs that promote bradycardia such as beta blockers;; Drug treatment for tachycardia (e.g., new onset beta blockers and calcium channel blockers).	48 postoperative hours.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Ryu Komatsu, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): January 6, 2026

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Anesthesia; Postoperative; Vital signs
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: 24-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared collaboratively upon approval of the Steering Committee and appropriate data-use agreement.
• IPD Sharing Time Frame: One year after publication of main paper.
• IPD Sharing Access Criteria: Contact PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

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