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.
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.
Study Type
OBSERVATIONAL
Enrollment
250
Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.
Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.
Cleveland Clinic
Cleveland, Ohio, United States
Phase 2- Cumulative Duration of Vital Sign Abnormalities
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.
Time frame: Up to 72 hours after surgery
Phase 2 - Alerts Deemed Meaningful
Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group
Time frame: During postoperative 72 hours
Phase 2 - Clinical Interventions to Meaningful Alarms
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.
Time frame: During postoperative 72 hours
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