Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05108376

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Deterioration, Clinical Clinical Deterioration Disease Attributes Disease Progression Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location status: Recruiting

Location contact

Alexandre Tran, MD, MSc, FRCSC

PRINCIPAL_INVESTIGATOR

Andrew JE Seely, MD, PhD, FRCSC

CONTACT

[email protected]

613-737-8899 ext. 74052

Christophe Herry, PhD

SUB_INVESTIGATOR

Jamie Brehaut, PhD

SUB_INVESTIGATOR

Jonathan Hooper

SUB_INVESTIGATOR

Kednapa Thavorn, PhD, MPharm, BPharm

SUB_INVESTIGATOR

Kwadwo Kyeremanteng

SUB_INVESTIGATOR

Michael Hartwick

SUB_INVESTIGATOR

Natasha Hudek, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Visensia Safety Index (VSI)

Device

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew JE Seely, MD, PhD, FRCSC

CONTACT

[email protected]

613-737-8899 ext. 74052

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Acronym: VSI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2021
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.