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

Recruiting

• Conditions: Postoperative Complications

• Registration Number: NCT06133140
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-15
• Study Start: 2024-02-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 856

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypoxemia	48 postoperative hours.	Area of oxygen saturation defined as SpO2 ≤85%.
Inadequate or excessive ventilation	48 postoperative hours.	Area of inadequate or excessive ventilation defined as respiratory rate ≤4/min or ≥30/min.
Bradycardia and tachycardia	48 postoperative hours.	Area of inadequate or excessive heart rate defined as ≤40/min or ≥130/min.

Secondary Outcome Measures

Name	Time	Method
The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.	48 postoperative hours.	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).

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States