Using viQtor for continuous monitoring of post-ICU patients
Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
Erasmus Medical Center · NCT06815718
This study is testing a new device called viQtor to see if it can help keep track of vital signs in patients recovering from the ICU and make sure they get the right care on the general ward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT06815718 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the viQtor device for continuous monitoring of vital signs in post-ICU patients on general wards. The primary objective is to develop a continuous Early Warning Score (c-EWS) based on data collected from the viQtor, which measures pulse rate, respiratory rate, oxygen saturation, and activity index. The study will also compare the c-EWS with the Modified Early Warning Score (MEWS) and assess patient and nurse satisfaction, as well as the technical feasibility of the device. Approximately 180 post-ICU patients will participate, wearing the viQtor for up to 5 days while receiving standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are expected to stay in the hospital for at least 2 days after ICU discharge.
Not a fit: Patients who cannot communicate in Dutch or English or have specific skin conditions affecting the upper arms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of clinical deterioration in post-ICU patients, potentially reducing readmissions.
How similar studies have performed: While similar approaches have been explored, this specific use of the viQtor device for continuous monitoring in post-ICU patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam, Zuid-Holland
- Erasmus MC — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Gerrie Prins, MD — Erasmus Medical Center
- Study coordinator: Michael v Herwerden, MD
- Email: m.vanherwerden@erasmusmc.nl
- Phone: +31107040704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Early Warning Score, Monitoring, Telemedicine-Based Education, Readmission, Rapid Response System, Early Warning, EWS, Telemonitoring