Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Erasmus Medical Center
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Development and Validation of a Continuous Early Warning Score (c-EWS) for Detecting Clinical Deterioration in Post-ICU Patients Using the viQtor System
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Telemonitoring group
Group wearing the ViQtor telemedicine solution for continuous monitoring
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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).)
- Patient Acceptability of the viQtor System: Likert Questionnaire Results(end of monitoring after 5 days.)
- Predictive Accuracy of c-EWS vs. MEWS for ICU Consultation or Rapid Response Team Intervention(5 days)
- Nurse Perspectives on the viQtor System: Thematic Analysis of Focus Group Results(At the end of the inclusion period)
- 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).)
Investigators
Michael Cornelis van Herwerden
Principal Investigator
Erasmus Medical Center