Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards (ViQtor)

February 15, 2026 updated by: Michael Cornelis van Herwerden, Erasmus Medical Center
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015GD
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Adults ≥18 years of age
  • Written informed consent is obtained from the patient
  • Expected hospitalization time after ICU discharge of 2 days or longer

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Telemonitoring group
Group wearing the ViQtor telemedicine solution for continuous monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of monitoring in 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Accuracy of c-EWS vs. MEWS for ICU Consultation or Rapid Response Team Intervention
Time Frame: 5 days
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.
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).
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.
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).
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.
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.
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.
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
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.
At the end of the inclusion period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Gerrie Prins, MD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2024-0647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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