Early Warning ScoreViQtorNCT06815718
Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
An observational study of Early Warning Score and Monitoring, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale Following ICU discharge, intermittent vital sign monitoring may delay timely recognition of clinical deterioration and lead to unnecessary readmissions. This study proposes the use of the viQtor continuous monitoring device to measure pulse rate (PR), respiratory rate (RR), oxygen saturation (SpO2) and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Warning Score, Monitoring, Telemedicine-Based Education
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Feb 2025to 30 Dec 2025
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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
Study population: This study will be conducted at Erasmus MC and will include 180 hospitalized adults (aged 18 years and older) who have received ICU care and are subsequently transferred to a general ward within the Erasmus MC.
Who may be able to join
- Adults ≥18 years of age
- Written informed consent is obtained from the patient
- Expected hospitalization time after ICU discharge of 2 days or longer
Who cannot join
- The patient is unable to communicate in Dutch or English
- The patient has an allergy to metal or plastics (as the viQtor device contains these materials)
- The patient has significant deformities, swelling, irritation, degenerative changes, local infection, ulceration, skin lesions, or edema of the upper arms.
- The patient has tattoos on both upper arms where the device's PPG sensor would be placed
- The patient experiences tremors/and or convulsions affecting the upper arm
Trial locations and contacts
1 site in 1 country.
About this study
Rationale Following ICU discharge, intermittent vital sign monitoring may delay timely recognition of clinical deterioration and lead to unnecessary readmissions. This study proposes the use of the viQtor continuous monitoring device to measure pulse rate (PR), respiratory rate (RR), oxygen saturation (SpO2) and the activity index in post-ICU patients on general wards. The primary aim is to develop a continuous Early Warning Score (c-EWS), determine its optimal cut-off values. The secondairy outcome will be a comparison with the Modified Early Warning Score (MEWS). In addition, patient and nurse satisfaction, as well as technical feasibility, will be assessed.
Read the detailed description
Objective(s) Primary: To develop and optimize a c-EWS using viQtor data for early detection of clinical deterioration in post-ICU patients.
Secondary: To evaluate the c-EWS's predictive accuracy relative to MEWS, to assess user satisfaction (patients and nurses), and to determine the technical feasibility of the viQtor device.
Study type This is a single-center prospective observational cohort study at general wards in post-discharge ICU patients.
Study population A single-center prospective observational cohort study will include approximately 180 post-ICU patients and 20 nurses at the Erasmus MC.
Methods Over a four-month period (winter/spring 2024-2025), patients transferred from the ICU to a general ward will wear the viQtor device for up to 5 days. Concurrent standard care involves MEWS measurements three times daily. No clinical decisions will be based on viQtor measurements, ensuring no interference with standard care. The c-EWS will be retrospectively derived and assessed using ROC analyses to determine optimal cut-off values. Comparisons with MEWS will be descriptive. Patient feedback will be collected via a brief questionnaire at discharge, and a semi-structured focus group with participating nurses will provide insights into user experiences.
Burden and risks The wearable viQtor device is noninvasive, comfortable, and worn continuously without affecting patient care or activities. Minor skin irritation is the only anticipated risk. Nurses' participation is limited to the focus group.
Recruitment and consent Patients will be screened in the last 48 hours of their ICU stay. Following informed consent, the viQtor device will be applied at the moment of transfer to the general ward. All participants will be fully informed about study procedures, potential risks, and their right to withdraw. Nurses will be invited via email to participate in the focus group and will provide informed consent before participation.
- Conditions
- Early Warning Score, Monitoring, Telemedicine-Based Education, Readmission, Rapid Response System
- Keywords
- Early Warning, EWS, Telemonitoring, continuous monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Group wearing the ViQtor telemedicine solution for continuous monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and Validation of a Continuous Early Warning Score (c-EWS) for Detecting Clinical Deterioration in Post-ICU Patients Using the viQtor System
A continuous early warning score (c-EWS) will be developed using the viQtor system to detect clinical deterioration in post-ICU patients on the general ward. Clinical deterioration is defined as an ICU consultation or a Rapid Response Team intervention. The optimal cut-off values for the c-EWS will be identified and evaluated using Receiver Operating Characteristic (ROC) curves and the Area Under the Curve (AUC) values.
Measured: From enrollment to the end of monitoring in 5 days
Secondary outcomes (5)
Predictive Accuracy of c-EWS vs. MEWS for ICU Consultation or Rapid Response Team Intervention
The predictive accuracy of the optimized continuous Early Warning Score (c-EWS) compared to the Modified Early Warning Score (MEWS) in predicting ICU consultation or Rapid Response Team (RRT) intervention will be assessed using descriptive statistics.
Measured: 5 days
Predictive Accuracy of c-EWS vs. MEWS for In-Hospital Cardiac Arrest, ICU Readmission, and Hospital Mortality
The predictive accuracy of the optimized c-EWS compared to the MEWS in predicting in-hospital cardiac arrest, ICU readmission, and hospital mortality will be assessed using descriptive statistics.
Measured: From enrollment to the end of monitoring (maximum 5 days).
Predictive Accuracy of c-EWS in Detecting Clinical Deterioration Within 8 Hours of an Event
The ability of the viQtor system's c-EWS to detect clinical deterioration within the eight hours preceding a documented deterioration event will be evaluated using descriptive statistics.
Measured: From enrollment to the end of monitoring (maximum 5 days).
Patient Acceptability of the viQtor System: Likert Questionnaire Results
Patient acceptability of using the viQtor solution will be assessed using a 5-point Likert questionnaire Responses will be analyzed descriptively to determine levels of acceptability.
Measured: end of monitoring after 5 days.
Nurse Perspectives on the viQtor System: Thematic Analysis of Focus Group Results
Nurses' perspectives on the usability and feasibility of the viQtor system will be evaluated through semi-structured focus groups. Results will be thematically analyzed to identify key themes regarding user experience and implementation challenges.
Measured: At the end of the inclusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start7 Feb 2025
- Primary completion1 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Warning ScoreStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Cornelis van Herwerden, Erasmus Medical Center
- Investigators
- Gerrie Prins, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815718
- Sponsor's protocol ID
- MEC-2024-0647
- Acronym
- ViQtor
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
- ClinicalTrials.gov ID
- NCT06815718
- Acronym / sponsor ID
- ViQtor / MEC-2024-0647
- Conditions
- Early Warning Score, Monitoring, Telemedicine-Based Education, Readmission, Rapid Response System
- Keywords
- Early Warning, EWS, Telemonitoring, continuous monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 7 Feb 2025 (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.
Rationale Following ICU discharge, intermittent vital sign monitoring may delay timely recognition of clinical deterioration and lead to unnecessary readmissions. This study proposes the use of the viQtor continuous monitoring device to measure pulse rate (PR), respiratory rate (RR), oxygen saturation (SpO2) and the activity index in post-ICU patients on general wards. The primary aim is to develop a continuous Early Warning Score (c-EWS), determine its optimal cut-off values. The secondairy outcome will be a comparison with the Modified Early Warning Score (MEWS). In addition, patient and nurse satisfaction, as well as technical feasibility, will be assessed.
Detailed description
Objective(s) Primary: To develop and optimize a c-EWS using viQtor data for early detection of clinical deterioration in post-ICU patients.
Secondary: To evaluate the c-EWS's predictive accuracy relative to MEWS, to assess user satisfaction (patients and nurses), and to determine the technical feasibility of the viQtor device.
Study type This is a single-center prospective observational cohort study at general wards in post-discharge ICU patients.
Study population A single-center prospective observational cohort study will include approximately 180 post-ICU patients and 20 nurses at the Erasmus MC.
Methods Over a four-month period (winter/spring 2024-2025), patients transferred from the ICU to a general ward will wear the viQtor device for up to 5 days. Concurrent standard care involves MEWS measurements three times daily. No clinical decisions will be based on viQtor measurements, ensuring no interference with standard care. The c-EWS will be retrospectively derived and assessed using ROC analyses to determine optimal cut-off values. Comparisons with MEWS will be descriptive. Patient feedback will be collected via a brief questionnaire at discharge, and a semi-structured focus group with participating nurses will provide insights into user experiences.
Burden and risks The wearable viQtor device is noninvasive, comfortable, and worn continuously without affecting patient care or activities. Minor skin irritation is the only anticipated risk. Nurses' participation is limited to the focus group.
Recruitment and consent Patients will be screened in the last 48 hours of their ICU stay. Following informed consent, the viQtor device will be applied at the moment of transfer to the general ward. All participants will be fully informed about study procedures, potential risks, and their right to withdraw. Nurses will be invited via email to participate in the focus group and will provide informed consent before participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | – | –Group wearing the ViQtor telemedicine solution for continuous monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted at Erasmus MC and will include 180 hospitalized adults (aged 18 years and older) who have received ICU care and are subsequently transferred to a general ward within the Erasmus MC.
Key inclusion criteria (3 listed)
- Adults ≥18 years of age
- Written informed consent is obtained from the patient
- Expected hospitalization time after ICU discharge of 2 days or longer
Key exclusion criteria (5 listed)
- The patient is unable to communicate in Dutch or English
- The patient has an allergy to metal or plastics (as the viQtor device contains these materials)
- The patient has significant deformities, swelling, irritation, degenerative changes, local infection, ulceration, skin lesions, or edema of the upper arms.
- The patient has tattoos on both upper arms where the device's PPG sensor would be placed
- The patient experiences tremors/and or convulsions affecting the upper arm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development and Validation of a Continuous Early Warning Score (c-EWS) for Detecting Clinical Deterioration in Post-ICU Patients Using the viQtor System
Time frame: From enrollment to the end of monitoring in 5 days
A continuous early warning score (c-EWS) will be developed using the viQtor system to detect clinical deterioration in post-ICU patients on the general ward. Clinical deterioration is defined as an ICU consultation or a Rapid Response Team intervention. The optimal cut-off values for the c-EWS will be identified and evaluated using Receiver Operating Characteristic (ROC) curves and the Area Under the Curve (AUC) values.
5 secondary outcomes
Predictive Accuracy of c-EWS vs. MEWS for ICU Consultation or Rapid Response Team Intervention
Time frame: 5 days
Predictive Accuracy of c-EWS vs. MEWS for In-Hospital Cardiac Arrest, ICU Readmission, and Hospital Mortality
Time frame: From enrollment to the end of monitoring (maximum 5 days).
Predictive Accuracy of c-EWS in Detecting Clinical Deterioration Within 8 Hours of an Event
Time frame: From enrollment to the end of monitoring (maximum 5 days).
Patient Acceptability of the viQtor System: Likert Questionnaire Results
Time frame: end of monitoring after 5 days.
Nurse Perspectives on the viQtor System: Thematic Analysis of Focus Group Results
Time frame: At the end of the inclusion period
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Rapid Response Teams - How and Who?
Hospital Rapid Response Team, Early Warning Score
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.
Gerrie Prins, MD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Warning Score and Monitoring, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 inclusion and 5 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 17 Feb 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 Netherlands. 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?
Development and Validation of a Continuous Early Warning Score (c-EWS) for Detecting Clinical Deterioration in Post-ICU Patients Using the viQtor System (time frame: From enrollment to the end of monitoring in 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.