What side effects are associated with this type of intervention?

The Visensia Safety Index (VSI) uses continuous vital sign monitoring and machine learning to predict patient deterioration. While the VSI itself is a monitoring tool and not a treatment, it is often used in conjunction with rapid response teams (RRTs) and early warning scores (EWS) to manage clinical deterioration. Common treatments for clinical deterioration include interventions by RRTs, which may involve medications, mechanical ventilation, and other critical care measures. Known side effects of these interventions can include medication-related adverse effects such as hypotension, arrhythmias, and infections from invasive procedures. Continuous monitoring systems like VSI generally have minimal direct side effects but can lead to increased patient anxiety and discomfort due to constant monitoring.

What prior FDA approvals exist?

The FDA has approved various technologies and treatments aimed at managing clinical deterioration, though specific approvals for systems exactly like the Visensia Safety Index (VSI) are not detailed in the provided context. Generally, continuous vital sign monitoring systems and machine learning algorithms are increasingly integrated into hospital settings to predict and manage patient deterioration. These systems analyze data such as vital signs and laboratory results to provide early warnings, potentially preventing severe outcomes. While specific FDA approvals for such integrated systems are not mentioned, the trend towards using advanced monitoring technologies in clinical settings is evident.

What other types of research exist?

Promising alternatives to the Visensia Safety Index for predicting clinical deterioration in 2024 include: 1) Predictive Monitoring Integrated with Rapid Response Teams (RRTs) using Early Warning Scores (EWS) that analyze vital signs and lab results, 2) High fidelity, bioinformatics-based electronic alert systems designed to improve targeted oxygenation in mechanically ventilated patients, and 3) Automated outcomes surveillance systems like DELTA, which use Statistical Process Control (SPC) and Bayesian Updating Statistics (BUS) for real-time monitoring and prediction.

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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

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

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 more

Secondary 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.

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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.

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