Evaluation of the viQtor Monitoring Solution on Surgical Wards (REQUEST)

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

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.

Study Overview

• Status: Completed
• Conditions: Monitoring; Patient Safety; Post-operative Monitoring; Healthcare Technology Implementation; Contiuous Vital Signs Monitoring
• Intervention / Treatment: Device: viQtor Wearable Monitoring Device

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623EJ
      • Catharina Hospital Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult post-operative patients admitted to the surgical ward at Catharina Hospital Eindhoven. The study will focus on evaluating the feasibility and effectiveness of continuous vital sign monitoring using the viQtor device.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Surgical Patients Monitored with viQtor; This group includes adult patients admitted to the surgical ward at Catharina Hospital Eindhoven. Participants in this group will be monitored continuously using the viQtor wearable device to track vital signs such as heart rate, respiratory rate, and blood oxygen saturation during their hospital stay. The focus is on evaluating the implementation, usability, and effectiveness of the viQtor solution in a real-world clinical setting.

Device: viQtor 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the viQtor Monitoring Solution	Evaluation 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.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Nursing Workload	Assessment 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.	8 months
Predictive Accuracy of the viQtor Solution	Evaluation 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.	8 months
Implementation Success of the viQtor Solution	Determination 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.	8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nurse and Physician Adoption of the viQtor Solution	Measurement of the level of adoption and acceptance of the viQtor solution among healthcare staff, assessed through the Evidence-Based Practice Attitude Scale (EBPAS).	8 months

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Simon S.W. Nienhuijs, Dr. PHD., Catharina Ziekenhuis Eindhoven

Publications and helpful links

General Publications

• Jerry EE, Bouwman ARA, van Esch EMG, Richardson R, Nienhuijs SW. Remote Monitoring With a Reusable Device Upon Implementation on a Surgical Department (REQUEST Trial). World J Surg. 2026 Mar;50(3):676-683. doi: 10.1002/wjs.70261. Epub 2026 Feb 11.
• Jerry EE, Bouwman AR, Nienhuijs SW. Remote Monitoring by ViQtor Upon Implementation on a Surgical Department (REQUEST-Trial): Protocol for a Prospective Implementation Study. JMIR Res Protoc. 2025 Jul 3;14:e70707. doi: 10.2196/70707.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Remote monitoring; Vital signs; Continuous monitoring; Healthcare technology; Post-operative care; Wearable medical device; viQtor solution
• Other Study ID Numbers: NL. REQUEST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to concerns about patient privacy and confidentiality. The data collected includes sensitive health information, and sharing it could risk breaching participant anonymity. Additionally, the study's data use agreements and local regulations do not permit the sharing of IPD with external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No