Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-I… (NCT06815718) | Clinical Trial Compass
CompletedNot Applicable
Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
Netherlands180 participantsStarted 2025-02-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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