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

Postoperative Complications Clinical Trial

— COSMOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133140
• Other study ID #: 24-009
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: Daniel I Sessler, MD
• Phone: 216-445-6500?
• Email: sessled[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 856
• Est. completion date: June 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Device:
• Unblinded postoperative vital sign monitoring
Unblinded postoperative GE Portrait monitoring
• Blinded postoperative vital sign monitoring
Blinded postoperative GE Portrait monitoring

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Area of oxygen saturation defined as SpO2 =85%.	48 postoperative hours.
Primary	Inadequate or excessive ventilation	Area of inadequate or excessive ventilation defined as respiratory rate =4/min or =30/min.	48 postoperative hours.
Primary	Bradycardia and tachycardia	Area of inadequate or excessive heart rate defined as =40/min or =130/min.	48 postoperative hours.
Secondary	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.