Evaluation of the viQtor Monitoring Solution on Surgical Wards

NCT06574867 | Completed

• 1 other identifier: NL. REQUEST
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction in Nursing Workload

  8 months

• Predictive Accuracy of the viQtor Solution

  8 months

• Implementation Success of the viQtor Solution

  8 months

Other Outcomes (1)

• Nurse and Physician Adoption of the viQtor Solution

  8 months

Study Arms (1)

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

Interventions

viQtor Wearable Monitoring Device 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.

Surgical Patients Monitored with viQtor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 41672938 DERIVED

• 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.

  PMID: 40608408 DERIVED

Study Officials

• Simon S.W. Nienhuijs, Dr. PHD.

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: October 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 1, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)