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

NCT06815718 | Completed

• 1 other identifier: MEC-2024-0647
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Early Warning Score; Monitoring; Telemedicine-Based Education; Readmission; Rapid Response System

Keywords

Early Warning; EWS; Telemonitoring; continuous monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  5 days

• Predictive Accuracy of c-EWS vs. MEWS for In-Hospital Cardiac Arrest, ICU Readmission, and Hospital Mortality

  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

  From enrollment to the end of monitoring (maximum 5 days).

• Patient Acceptability of the viQtor System: Likert Questionnaire Results

  end of monitoring after 5 days.

• Nurse Perspectives on the viQtor System: Thematic Analysis of Focus Group Results

  At the end of the inclusion period

Study Arms (1)

Telemonitoring group

Group wearing the ViQtor telemedicine solution for continuous monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

Study Officials

• Gerrie Prins, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 7, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 30, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

NL (1)