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Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team

Study acronym: VSI
StatusCompleted
PhaseNot applicable
Started2023-09-19
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
notable
Study Status, Study Design, Contacts/Locations v4
Trial completed
Final enrollment: 41 participants (planned 140)
Primary completion confirmed: March 2025 (last estimated September 2025)
Primary completion dateestimated 2025-09→confirmed 2025-03-06
Completion dateestimated 2025-09→confirmed 2025-03-25
Enrollment targetestimated 140→confirmed 41
Study sitesdetails revised at 1 of 1 site
2025-05-09
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-01→2025-09
Completion date2024-01→2025-09
Start dateestimated 2023-01→confirmed 2023-09-19
Eligibility criteria-47 characters
[...] els 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 ha [...] rd Other high-risk patients determined at the discretion of RACE physician with agreement from the patient'sclinical most responsible physicians (MRP)team Exclusion Criteria: Patients admitted to a unit with higher [...] rauma Step-Down, Intensive Care Unit) Patients with Category II (Full Care except CPR), III (Full Care except Respiratory or Hemodynamic Life Support, or CPR) or IV status (Comfort Care)
Study sitesdetails revised at 1 of 1 site
2022-09-22
minor
Study Status v2
Primary completion date2023-06→2024-01
Completion date2023-06→2024-01
Start date2022-06→2023-01
2022-03-14
minor
Study Status v1
Primary completion date2023-02→2023-06
Completion date2023-02→2023-06
Start date2022-02→2022-06
2021-11-02
minor
Original filing
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.
Trial Details
NCT Number NCT05108376
Lead Sponsor Ottawa Hospital Research Institute
Conditions Deterioration, Clinical
Enrollment 41 participants
Start Date 2023-09-19
Primary Completion 2025-03-06 (estimated)
Study Completion 2025-03-25 (estimated)
Updated on ClinicalTrials.gov 2026-09-08