Predictive Monitoring for Clinical Deterioration

(VSI Trial)

Overseen By Andrew JE Seely, MD, PhD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Higher level monitoring, Category III/IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new monitoring system called the Visensia Safety Index (VSI). The goal is to determine if this system can help doctors detect early signs of health problems in hospital patients, enabling prompt action. The trial includes adults who have undergone high-risk surgeries, certain cancer patients at risk of deterioration, and patients with infections admitted from the emergency room. This system might prevent serious health issues and reduce the need for intensive care. As an unphased trial, it offers patients the chance to contribute to innovative healthcare solutions that could enhance patient safety and outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Visensia Safety Index (VSI) is safe for monitoring patient deterioration?

Research has shown that the Visensia Safety Index (VSI) tracks vital signs like heart rate and blood pressure. It helps identify patients at risk of serious health problems before conditions worsen. In past studies, VSI reduced the time patients spent in unstable conditions and decreased the number of serious health episodes.

The system has been tested in real hospitals and alerts medical staff early if a patient's condition might deteriorate. This allows potential problems to be addressed sooner, possibly preventing more serious health issues.

The VSI is non-invasive, meaning it doesn't involve surgery or entering the body. So far, studies have not reported any major safety concerns, making it generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Visensia Safety Index (VSI) because it offers a novel approach to monitoring patient health. Unlike traditional methods that rely on individual vital signs to detect patient deterioration, VSI uses an advanced algorithm to analyze multiple vital signs simultaneously. This allows for earlier detection of potential health declines, enabling rapid intervention and potentially improving patient outcomes. By alerting healthcare staff to subtle changes before they become critical, VSI could revolutionize how hospitals manage patient safety.

What evidence suggests that the Visensia Safety Index is effective for identifying clinical deterioration?

Research shows that the Visensia Safety Index (VSI), which participants in this trial will experience, effectively predicts when hospital patients might deteriorate. Studies have found that VSI can detect warning signs hours before doctors and nurses usually can. It continuously monitors vital signs like heart rate and blood pressure and uses a smart computer system to provide early alerts. Initial results suggest that patients with VSI monitoring experienced shorter periods of instability and fewer serious incidents. At The Ottawa Hospital, a study indicated that using an early warning score could have identified problems sooner in over half of the cases, possibly preventing serious outcomes like ICU admission. ^{2 4 5 6 7}

Who Is on the Research Team?

Andrew JE Seely, MD, PhD, FRCSC

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Malignant haematology or oncology patients at high risk for deterioration

Patients who have undergone high risk elective surgery (Whipple procedures, high risk vascular surgery, high risk general surgery, among others)

Patients with infection admitted from the Emergency Department (ED) to the ward

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 II (Full Care except CPR), III (Full Care except Respiratory or Hemodynamic Life Support, or CPR) or IV status (Comfort Care)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Visensia Safety Index (VSI) to alert RACE staff of patient deterioration

10 months

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after implementation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visensia Safety Index (VSI)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. obsmedical.com obsmedical.com/visensia-the-safety-index/

Visensia ® – The Safety Index Visensia® – The Safety Index™ is a clinical measurement that can identify patients at risk of significant deterioration hours before most physicians and nurses ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11577488/

Efficacy of Early Warning Scores as the Prediction Tool for ... This study evaluates the effectiveness of NEWS and VSI in predicting patient deterioration in an HDU in Japan.

3. researchprotocols.org researchprotocols.org/2025/1/e65360

Assessing Clinical Impressions of Early Warning Score ... The Visensia Safety Index (VSI) is an EWS that combines heart rate, blood pressure, temperature, oxygen saturation, and respiration rate vital ...

4. link.springer.com link.springer.com/article/10.1007/s10916-023-01954-z

Comparing Continuous with Periodic Vital Sign Scoring for ... It was shown that continuous vital signs monitoring in combination with an appropriate risk score algorithm (Visensia Safety Index, VSI) equaled ...

5. anandic.com anandic.com/en/products/produkt-detail/visensia-the-safety-index/

Visensia - The Safety Index The Visensia Safety Index works by comparing the patient's vital signs; heart rate, blood oxygen saturation, respiration rate, temperature and blood pressure, ...

6. nice.org.uk nice.org.uk/guidance/mib36/resources/visensia-for-early-detection-of-deteriorating-vital-signs-in-adults-in-hospital-pdf-63499108954309

Visensia for early detection of deteriorating vital signs in ... Visensia software analyses data on a patient's heart rate, blood pressure, temperature, oxygen saturations and respiration rate to generate a ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37154986/

Comparing Continuous with Periodic Vital Sign Scoring for ... This might be prevented by continuous vital sign monitoring with a real-time algorithm such as the Visensia Safety Index (VSI). This prospective ...