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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon study completion, 10 months after study initiation
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new monitoring system called the Visensia Safety Index (VSI) to help hospital staff quickly identify patients whose health is getting worse. The system regularly checks vital signs and uses smart technology to predict problems early. The goal is to see if this system can help prevent serious health issues and reduce the need for intensive care.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon study completion, 10 months after study initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon study completion, 10 months after study initiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Evaluate potential clinical impact of the VSI
Evaluate potential financial impact of the VSI
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for clinical deterioration, particularly those studied in the Visensia Safety Index (VSI) trial, involve continuous vital sign monitoring and machine learning. Continuous monitoring collects real-time data on vital signs such as heart rate, respiratory rate, blood pressure, and oxygen saturation.
Machine learning algorithms then analyze this data to detect early signs of deterioration. This predictive approach enables healthcare providers to intervene promptly, potentially preventing further decline and improving patient outcomes.
Early detection and intervention are critical in managing clinical deterioration, as they can reduce the severity and duration of patient instability.
Kidney transplantation and cardiomyopathy: Concepts and controversies in clinical decision-making.Treatment of infections caused by multidrug-resistant Gram-negative bacteria: report of the British Society for Antimicrobial Chemotherapy/Healthcare Infection Society/British Infection Association Joint Working Party.Controversies in the management of acute tonsillitis: an evidence-based review.
Kidney transplantation and cardiomyopathy: Concepts and controversies in clinical decision-making.Treatment of infections caused by multidrug-resistant Gram-negative bacteria: report of the British Society for Antimicrobial Chemotherapy/Healthcare Infection Society/British Infection Association Joint Working Party.Controversies in the management of acute tonsillitis: an evidence-based review.
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
573 Previous Clinical Trials
3,094,291 Total Patients Enrolled
Andrew JE Seely, MD, PhD, FRCSCPrincipal InvestigatorThe Ottawa Hospital
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The study doctor and your regular doctor agree that you are a high-risk patient for this study.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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