Deterioration, ClinicalVSINCT05108376
Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team
A study testing Visensia Safety Index (VSI) in people with Deterioration, Clinical, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deterioration, Clinical
- What is being tested?
- Visensia Safety Index (VSI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2023to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Deterioration, Clinical
- Being tested
- Visensia Safety Index (VSI)
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration. Receives: Device: Visensia Safety Index (VSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate technical feasibility of collecting greater than 80% of continuous data
Feasibility of continuous data collection will be evaluated by determining if greater than 80% of continuous data can be collected
Measured: Upon study completion, 10 months after study initiation
Evaluate technical feasibility of feeding greater then 80% of continuous data to the predictive tool
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
Measured: Upon study completion, 10 months after study initiation
Evaluate technical feasibility of updating the predictive tool on a regular basis greater than 80% of the time
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
Measured: Upon study completion, 10 months after study initiation
Evaluate technical feasibility of reporting greater then 80% of triggers to the RACE team
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
Measured: Upon study completion, 10 months after study initiation
Evaluate clinical feasibility by assessing MD opinions of the VSI
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
Measured: Upon study completion, 10 months after study initiation
Evaluate clinical feasibility by assessing RN opinions of the VSI
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
Measured: Upon study completion, 10 months after study initiation
Evaluate clinical feasibility by assessing RT opinions of the VSI
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
Measured: Upon study completion, 10 months after study initiation
Evaluate financial feasibility of implementing the VSI system
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
Measured: Upon study completion, 10 months after study initiation
Secondary outcomes (2)
Evaluate potential clinical impact of the VSI
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.
Measured: Upon study completion, 10 months after study initiation
Evaluate potential financial impact of the VSI
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
Measured: Upon study completion, 10 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start19 Sep 2023
- Primary completion6 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deterioration, ClinicalStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew JE Seely, MD, PhD, FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108376
- Sponsor's protocol ID
- 3199
- Acronym
- VSI
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran A, Ramchandani R, Brehaut J, Hudek N, Haines J, Watpool I, Porteous R, Kusevic D, Bucciero K, Kyeremanteng K, Hartwick M, Thavorn K, Hooper J, Kubelik D, Herry C, Scales N, Hryciw B, Abou-Khalil J, Perry J, Bredeson C, Seely A. Assessing Clinical Impressions of Early Warning Score Integration With the Rapid Response Team: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Jul 31;14:e65360. doi: 10.2196/65360.
PubMed 40742731
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team
- ClinicalTrials.gov ID
- NCT05108376
- Acronym / sponsor ID
- VSI / 3199
- Conditions
- Deterioration, Clinical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Visensia Safety Index (VSI)The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visensia Safety Index (VSI)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. | Device | Intervention Arm |
Primary outcome
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
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
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
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
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
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
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
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
2 secondary outcomes
Evaluate potential clinical impact of the VSI
Time frame: Upon study completion, 10 months after study initiation
Evaluate potential financial impact of the VSI
Time frame: Upon study completion, 10 months after study initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 40742731Tran A, Ramchandani R, Brehaut J, Hudek N, Haines J, Watpool I, Porteous R, Kusevic D, Bucciero K, Kyeremanteng K, Hartwick M, Thavorn K, Hooper J, Kubelik D, Herry C, Scales N, Hryciw B, Abou-Khalil J, Perry J, Bredeson C, Seely A. Assessing Clinical Impressions of Early Warning Score Integration With the Rapid Response Team: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Jul 31;14:e65360. doi: 10.2196/65360.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew JE Seely, MD, PhD, FRCSC principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visensia Safety Index (VSI) in people with Deterioration, Clinical, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate technical feasibility of collecting greater than 80% of continuous data (time frame: Upon study completion, 10 months after study initiation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.