Clinical trial NCT06815718: Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
Official title: Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early Warning Score
Monitoring
Telemedicine-Based Education
Readmission
Rapid Response System
Keywords: Early Warning
EWS
Telemonitoring
continuous monitoring
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development and Validation of a Continuous Early Warning Score (c-EWS) for Detecting Clinical Deterioration in Post-ICU Patients Using the viQtor System
timeFrame: From enrollment to the end of monitoring in 5 days
Secondary outcomes:
measure: Predictive Accuracy of c-EWS vs. MEWS for ICU Consultation or Rapid Response Team Intervention
timeFrame: 5 days
measure: Predictive Accuracy of c-EWS vs. MEWS for In-Hospital Cardiac Arrest, ICU Readmission, and Hospital Mortality
timeFrame: From enrollment to the end of monitoring (maximum 5 days).
measure: Predictive Accuracy of c-EWS in Detecting Clinical Deterioration Within 8 Hours of an Event
timeFrame: From enrollment to the end of monitoring (maximum 5 days).
measure: Patient Acceptability of the viQtor System: Likert Questionnaire Results
timeFrame: end of monitoring after 5 days.
measure: Nurse Perspectives on the viQtor System: Thematic Analysis of Focus Group Results
timeFrame: At the end of the inclusion period
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Gerrie Prins, MD
role: PRINCIPAL_INVESTIGATOR
References: