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

September 3, 2026 updated by: Ottawa Hospital Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Andrew JE Seely, MD, PhD, FRCSC
  • Phone Number: 74052 613-737-8899
  • Email: aseely@toh.ca

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm
The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate technical feasibility of collecting greater than 80% of continuous data
Time Frame: Upon study completion, 10 months after study initiation
Feasibility of continuous data collection will be evaluated by determining if greater than 80% of continuous data can be collected
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
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
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
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
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
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
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
Clinical feasibility will be evaluated by assessing MD opinions regarding understanding of the predictive tool, ease of use, perceived strengths and limitations, and perceived enablers and barriers to effective usage through post-encounter surveys and interviews
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
Clinical feasibility will be evaluated by assessing RN opinions regarding understanding of the predictive tool, ease of use, perceived strengths and limitations, and perceived enablers and barriers to effective usage through post-encounter surveys and interviews
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
Clinical feasibility will be evaluated by assessing RT opinions regarding understanding of the predictive tool, ease of use, perceived strengths and limitations, and perceived enablers and barriers to effective usage through post-encounter surveys and interviews
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
Financial feasibility of implementing the VSI system will be evaluated by identifying the costs related to implementation and maintenance of the portable continuous monitoring system through health economic evaluation
Upon study completion, 10 months after study initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate potential clinical impact of the VSI
Time Frame: Upon study completion, 10 months after study initiation
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.
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
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
Upon study completion, 10 months after study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew JE Seely, MD, PhD, FRCSC, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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