Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Visensia Safety Index (VSI).
- Who it may be relevant to
- Registry conditions: Deterioration, Clinical. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Visensia Safety Index (VSI)
Enrolled 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.
Primary outcome measures
- Evaluate technical feasibility of collecting greater than 80% of continuous data [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate technical feasibility of feeding greater then 80% of continuous data to the predictive tool [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate technical feasibility of updating the predictive tool on a regular basis greater than 80% of the time [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate technical feasibility of reporting greater then 80% of triggers to the RACE team [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate clinical feasibility by assessing MD opinions of the VSI [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate clinical feasibility by assessing RN opinions of the VSI [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate clinical feasibility by assessing RT opinions of the VSI [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate financial feasibility of implementing the VSI system [Time frame: Upon study completion, 10 months after study initiation]
Secondary outcome measures (2)
- Evaluate potential clinical impact of the VSI [Time frame: Upon study completion, 10 months after study initiation]
- Evaluate potential financial impact of the VSI [Time frame: Upon study completion, 10 months after study initiation]
Eligibility criteria
Inclusion criteria
Adult patient (greater than or equal to 18 years of age) designated for the most aggressive levels of potential intervention (Category 1 status - Full Care and Category 2 status - Full Care except CPR) who belong to one of the following groups:
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- The Ottawa Hospital — Ottawa
Publications
- Tran A, Ramchandani R, Brehaut J, Hudek N, Haines J, Watpool I, Porteous R, Kusevic D, Bucciero K, Kyeremanteng K, Hartwick M, Thavorn K, Hooper J, Kubelik D, Herry C, Scales N, Hryciw B, Abou-Khalil J, Perry J, Bredeson C, Seely A. Assessing Clinical Impressions of Early Warning Score Integration With the Rapid Response Team: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Jul 31;1 PMID 40742731
Identifiers
NCT: NCT05108376 · 3199