The COSMOS Trial. A Pilot Study A Pilot Study

Completed

Conditions: Surgery

Interventions: Device: GE Portrait Monitor
Device: GE Portrait Monitoring randomized to blinded or unblinded
Device: GE Portrait Monitoring with intervened by clinician

Registration Number: NCT05280574

Lead Sponsor: The Cleveland Clinic

Brief Summary: The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. Data obtained in the proposed pilot cohort will guide design of a future robust randomized trial comparing clinical interventions and serious complications with blinded versus unblinded continuous ward monitoring.

Detailed Description: The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. The system is a novel battery-powered untethered monitor for continuous monitoring of oxygen saturation, respiratory rate, and pulse rate that is designed for use by patients on surgical wards. The initial phase will evaluate patient tolerance, with clinicians and patients blinded to monitor data. Results will be used to evaluate the frequency of respiratory events and pulse rate abnormalities. These data will be used to design clinical alert settings, based on various durations at various thresholds (e.g., saturation \<85% for \>1 minute). Our main goal will be to identify clinically meaningful vital sign abnormalities with a minimum of false alerts. Secondarily, the investigators will evaluate the frequency and duration of abnormalities, and the fraction that are detected clinically.

In the second phase of the pilot, clinicians will be unblinded to the GE Portrait monitors, and alerts provided based on the durations and threshold identified in the initial part of the pilot. The primary outcomes will be clinician tolerance and the extent to which clinicians believe that vital sign trending and alerts provided useful information rather than distraction. Specifically, the investigators will assess the fraction of alerts that clinicians deemed meaningful, and the fraction that resulted in clinical interventions. In the third phase of the pilot, the durations and thresholds for saturation, respiratory rate, and pulse rate that trigger alerts will be adjusted based on results from the second phase.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 250

Inclusion Criteria

Are admitted to one of the wards equipped with the GE Portrait Mobile Solution.
Are designated American Society of Anesthesiologists physical status 1-4.
Had major noncardiac surgery lasting at least 1.5 hours.
Are expected to remain hospitalized at least two postoperative nights.
Had general anesthesia with or without neuraxial anesthesia.

Exclusion Criteria

Have language, vision, or hearing impairments that may compromise continuous monitoring.
Are designated Do Not Resuscitate, hospice, or receiving end of life care
Have previously participated in the study.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monitoring without any interventions	GE Portrait Monitor	All patients will only be monitored with the GE Portrait Monitor with out any interventions.
Monitoring without any interventions	GE Portrait Monitoring randomized to blinded or unblinded	All patients will only be monitored with the GE Portrait Monitor with out any interventions.
Patients will be randomized to blinded or unblinded GE Portrait monitoring.	GE Portrait Monitoring with intervened by clinician	All patients will be monitored with the GE Portrait Monitor. Patients who are randomized to the unblinded GE Portrait monitoring might be intervened if the clinicians believe that the alarm is clinically meaningful. Blinded GE Portrait Monitoring will not receive clinicians believe clinically
Patients will be randomized to blinded or unblinded GE Portrait monitoring.	GE Portrait Monitor	All patients will be monitored with the GE Portrait Monitor. Patients who are randomized to the unblinded GE Portrait monitoring might be intervened if the clinicians believe that the alarm is clinically meaningful. Blinded GE Portrait Monitoring will not receive clinicians believe clinically

Primary Outcome Measures

Name	Time	Method
Phase 2- Cumulative Duration of Vital Sign Abnormalities	Up to 72 hours after surgery	The vital sign abnormalities is a 5-component composite including the durations of SpO2 \<85%, heart rate \<45/min, heart rate \>130/min, respiratory rate \<4/min and respiratory rate \>30/min.

Secondary Outcome Measures

Name	Time	Method
Phase 2 - Alerts Deemed Meaningful	During postoperative 72 hours	Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group
Phase 2 - Clinical Interventions to Meaningful Alarms	During postoperative 72 hours	Number of clinical interventions by the three categories of meaningful alarms (informative, important, and critical). An investigator will ask the relevant clinician (usually a nurse) to rate each alert as clinically meaningful or not. Specifically, clinicians will be asked to rate alerts as "critical," "important," "informative," or "false or distracting." The terms will intentionally not be further defined, thereby allowing caregivers to determine themselves the extent to which a given alert was helpful or not. Caregivers will be queried in person shortly after each alert, typically within 15 minutes. The thresholds, determined in the initial phase, will be set to generate an average of about 2 alerts per patient per day - and therefore will not be onerous for clinicians.