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

Study Overview
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Brief Summary
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We 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
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Device: Unblinded postoperative vital sign monitoring
* Device: Blinded postoperative vital sign monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Postoperative patients will be assigned to blinded or unblinded continuous vital sign monitoring
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Blinded monitoring<br>Continuous postoperative vital sign monitoring blinded to clinicians and investigators. | Device: Blinded postoperative vital sign monitoring<br>* Blinded postoperative GE Portrait monitoring<br>* Other names: Blinded group;|
| Experimental: Unblinded monitoring<br>Continuous postoperative vital sign monitoring unblinded to clinicians and investigators. | Device: Unblinded postoperative vital sign monitoring<br>* Unblinded postoperative GE Portrait monitoring<br>* Other names: Unblinded group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital sign abnormalities in patients recovering from major noncardiac surgery. | Our primary outcomes will be abnormalities in saturation, respiratory rate, and heart rate defined by area of: SpO2 ≤85%; Pulse rate ≤40/min or ≥130/min; Respiratory rate ≤4/min or ≥30/min. | 48 postoperative hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have interventions for 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Postoperative, Vital signs