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Evaluation of the viQtor Monitoring Solution on Surgical Wards

REQUEST - RemotE Monitoring by viQtor Upon Implementation on a Surgical departmenT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06574867
Acronym
REQUEST
Enrollment
500
Registered
2024-08-28
Start date
2024-10-01
Completion date
2025-12-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contiuous Vital Signs Monitoring, Healthcare Technology Implementation, Monitoring, Patient Safety, Post-operative Monitoring

Keywords

Continuous monitoring, Post-operative care, Vital signs, Healthcare technology, Wearable medical device, viQtor solution, Remote monitoring

Brief summary

The REQUEST study aims to evaluate the use of a new wireless monitoring device, called the viQtor solution, on a surgical ward in Catharina Hospital Eindhoven. This device continuously tracks vital signs, such as heart rate, breathing rate, and blood oxygen levels, in patients after surgery. The goal is to see if the viQtor solution can help detect health problems earlier and reduce the workload for nurses by minimizing the need for manual checks. The study will involve 500 patients and will take place over 7 months.

Detailed description

Detailed Description This is a prospective implementation evaluation study of the viQtor solution, a wearable medical device designed for continuous monitoring of vital signs in post-operative patients. The study will be conducted at the Catharina Hospital Eindhoven on the surgical ward "5 Oost" and will be divided into two phases, each involving approximately 250 patients. In Phase 1 (Months 1-3), patients will continue to receive standard care, which includes manual spot checks and Modified Early Warning Score (MEWS) assessments by nursing staff. During this phase, healthcare professionals will receive training on how to use the viQtor solution. In the Evaluation and Validation Period (Month 4), the accuracy of the viQtor device will be validated by comparing its continuous monitoring data with the manual measurements taken by nurses. In Phase 2 (Months 5-7), the viQtor solution will become the primary method for monitoring patients, with manual checks conducted only when necessary. The study aims to assess the viQtor solution's usability, acceptance, adoption by healthcare professionals, and its accuracy in detecting patient deterioration. It will also evaluate the feasibility of implementing this technology in a real-world hospital setting and its impact on clinical outcomes. The viQtor solution is a CE-marked Class IIa medical device, ensuring compliance with European safety standards. It is designed to be worn on the upper arm and is capable of wirelessly transmitting data every five minutes to a cloud-based platform accessible to healthcare professionals. Participants in this study will include adult patients admitted to the surgical ward for various procedures. The study will not only assess the technical performance of the viQtor solution but also its impact on the workflow and workload of healthcare providers. Data collected during the study will be used to determine the potential benefits and challenges of implementing continuous monitoring technology in hospital settings. The ultimate goal is to improve patient safety and outcomes through early detection of health deterioration, while also reducing the burden on nursing staff. If successful, this study could pave the way for broader adoption of wearable monitoring technology in hospitals, potentially setting a new standard of care for post-operative patients. This detailed description provides a comprehensive overview of the study objectives, methodology, and expected outcomes without duplicating information entered elsewhere in the record.

Interventions

DEVICEviQtor Wearable Monitoring Device

The viQtor device is a wearable medical device designed for continuous monitoring of vital signs, including heart rate (PR), respiratory rate (RR), and blood oxygen saturation (SpO2). It is worn on the upper arm and transmits data wirelessly to a cloud-based platform. This device is being evaluated as part of the standard monitoring protocol for post-operative patients in a surgical ward setting.

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (18 years and older). * Patients admitted to the surgical ward at Catharina Hospital Eindhoven. * Fluent in Dutch or English. * Willingness to participate in the study and to wear the viQtor monitoring device during their hospital stay.

Exclusion criteria

Patients with cognitive impairments. * Patients with allergies to metal or plastics. * Patients with significant deformities, swelling, irritation, degenerative changes, or edema of the upper arm. * Patients with implanted cardiac pacemakers, internal cardioverter defibrillators, or chronic resynchronization therapy devices. * Patients at risk of vascular compromise of the arm on which the device will be placed. * Patients with conditions that contraindicate the use of a blood pressure cuff or similar devices.

Design outcomes

Primary

MeasureTime frameDescription
Usability of the viQtor Monitoring Solution8 monthsEvaluation of the usability of the viQtor solution based on the System Usability Scale (SUS). The outcome will be measured by the SUS score, with a target score of \>68 indicating acceptable usability.

Secondary

MeasureTime frameDescription
Reduction in Nursing Workload8 monthsAssessment of the reduction in nursing workload by comparing the time spent on manual spot checks before and after implementing the viQtor solution. Success is defined as a 20% reduction in time spent on manual checks.
Predictive Accuracy of the viQtor Solution8 monthsEvaluation of the viQtor solution's accuracy in predicting patient deterioration by comparing the continuous vital sign measurements (SpO2, PR, RR) with intermittent measurements conducted as part of the MEWS protocol.
Implementation Success of the viQtor Solution8 monthsDetermination of the successful implementation of the viQtor solution, measured by the percentage of available and usable data (\>70%) collected from the device during the study period.

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORSimon S.W. Nienhuijs, Dr. PHD.

Catharina Ziekenhuis Eindhoven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026