Skip to main content
OpenTrials
Completed

NCT Number: NCT06133140

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Unblinded postoperative vital sign monitoring

Device

Unblinded postoperative GE Portrait monitoring

Other names: Unblinded group

Blinded postoperative vital sign monitoring

Device

Blinded postoperative GE Portrait monitoring

Other names: Blinded group

Primary outcomes

  1. Hypoxemia

    Time frame: 48 postoperative hours.

    Area of oxygen saturation defined as SpO2 ≤85%.

  2. Inadequate or excessive ventilation

    Time frame: 48 postoperative hours.

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

  3. Bradycardia and tachycardia

    Time frame: 48 postoperative hours.

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

Secondary outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: COSMOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2023
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.