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Predictive Monitoring for Clinical Deterioration (VSI Trial)

N/A
Waitlist Available
Led By Andrew JE Seely, MD, PhD, FRCSC
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Other high-risk patients determined at the discretion of RACE physician with agreement from the patient's most responsible physicians (MRP)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon study completion, 10 months after study initiation
Awards & highlights

VSI Trial Summary

This trial is testing a machine that uses data from vital signs and lab results to predict which hospitalized patients are at risk of deterioration. The machine is portable, so it can be used anywhere in the hospital. The goal is to see if using this machine can help identify patients at risk of deterioration earlier, so that they can be treated before their condition gets worse.

Who is the study for?
This trial is for adults over 18 in critical care (Category 1 - Full Care) at The Ottawa Hospital. It includes those who've had high-risk surgeries, infections from the ER, or are at risk of deterioration due to severe blood disorders or cancer. Patients already in units with advanced monitoring or with limited intervention wishes are not eligible.Check my eligibility
What is being tested?
The study tests a system called Visensia Safety Index (VSI), which uses continuous vital sign monitoring and machine learning to predict patient deterioration. It aims to see if VSI can help rapid response teams intervene sooner and reduce ICU admissions, illness severity, and death.See study design
What are the potential side effects?
Since the VSI is a predictive monitoring tool rather than a medication or invasive procedure, it does not have direct side effects like drugs do. However, there may be indirect consequences related to how clinical staff respond to its alerts.

VSI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The study doctor and your regular doctor agree that you are a high-risk patient for this study.

VSI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon study completion, 10 months after study initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon study completion, 10 months after study initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate clinical feasibility by assessing MD opinions of the VSI
Evaluate clinical feasibility by assessing RN opinions of the VSI
Evaluate clinical feasibility by assessing RT opinions of the VSI
+5 more
Secondary outcome measures
Evaluate potential clinical impact of the VSI
Evaluate potential financial impact of the VSI

VSI Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
559 Previous Clinical Trials
2,785,412 Total Patients Enrolled
Andrew JE Seely, MD, PhD, FRCSCPrincipal InvestigatorThe Ottawa Hospital
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Visensia Safety Index (VSI) Clinical Trial Eligibility Overview. Trial Name: NCT05108376 — N/A
Clinical Deterioration Research Study Groups: Intervention Arm
Clinical Deterioration Clinical Trial 2023: Visensia Safety Index (VSI) Highlights & Side Effects. Trial Name: NCT05108376 — N/A
Visensia Safety Index (VSI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108376 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants currently being enlisted for this research?

"The current information on clinicaltrials.gov indicates that this medical trial has temporarily stopped recruiting patients; the initial posting was made January 1st, 2023 and it last modified September 22nd 2022. Nevertheless, there are 5 active trials for which recruitment is still open at present."

Answered by AI
~65 spots leftby Mar 2025