About this trial
Rapid response teams (RRTs) have been adopted by hospitals to provide urgent critical care to hospitalized patients who require quick intervention to prevent further deterioration. Early warning scores (EWS) serve as a method to identify patients requiring RRT assessment by analyzing routinely collected data such as vital signs and laboratory results. The Visensia Safety Index (VSI) is an EWS that uses continuous vital sign monitoring and machine learning to identify the likelihood of deterioration and can be integrated with existing hospital data infrastructure. Initial studies of the VSI have both validated the system and found that patients monitored using VSI had a shorter duration of any instability and fewer episodes of serious and persistent instability. The investigators' recent retrospective analysis at The Ottawa Hospital (TOH) identified that implementation of an EWS could have detected earlier deterioration in over half of the patients identified, potentially preventing subsequent ICU admission, severity of illness, and/or mortality. Thus, this study aims to determine the feasibility and potential impact of implementing a portable continuous monitoring system with a VSI trigger at TOH to identify patients at high risk of deterioration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have undergone high risk elective surgery (Whipple procedures, high risk vascular surgery, high risk general surgery, among others)
Malignant haematology or oncology patients at high risk for deterioration
Patients with infection admitted from the Emergency Department (ED) to the ward
Other high-risk patients determined at the discretion of the clinical team
Disqualifiers
Patients admitted to a unit with higher level monitoring (Neurological Acute Assessment Unit, Acute Monitoring Area, Trauma Step-Down, Intensive Care Unit)
Patients with Category III (Full Care except Respiratory or Hemodynamic Life Support, or CPR) or IV status (Comfort Care)
Trial design
Single group
Treatments tested in this trial
Visensia Safety Index (VSI)
DeviceEnrolled patients will undergo continuous vital sign monitoring, to be used by the Visensia Safety Index (VSI) to identify early deterioration. If early deterioration is identified, the VSI will produce an alert to notify the RACE team.
Treatment groups
Trial outcomes
Primary outcomes
Evaluate technical feasibility of collecting greater than 80% of continuous data
Feasibility of continuous data collection will be evaluated by determining if greater than 80% of continuous data can be collected
Evaluate technical feasibility of feeding greater then 80% of continuous data to the predictive tool
Feasibility of feeding continuous data to the predictive tool will evaluated by determining if greater than 80% of continuous data can be fed to the predictive tool
Evaluate technical feasibility of updating the predictive tool on a regular basis greater than 80% of the time
Feasibility of updating the predictive tool on a regular basis will be evaluated by determining if greater than 80% of the time the predictive tool can be updated on a regular basis
Evaluate technical feasibility of reporting greater then 80% of triggers to the RACE team
Feasibility of reporting triggers to the RACE team will be evaluated by determining if greater than 80% of triggers are reported to the RACE team
Secondary outcomes
Evaluate potential clinical impact of the VSI
The potential clinical impact of the VSI will be evaluated by comparing the prognostic accuracy of the VSI trigger to clinical gestalt using statistical analysis of performance measures including sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve.
Evaluate potential financial impact of the VSI
The potential financial impact of the VSI will be evaluated by estimating the potential cost savings related to earlier detection of potential deterioration with comparison to historical RACE cohort
Sponsors and contacts
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