MonitoringREQUESTNCT06574867
Evaluation of the viQtor Monitoring Solution on Surgical Wards
An observational study of Monitoring and Post-operative Monitoring, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monitoring, Post-operative Monitoring, Patient Safety
- What is being tested?
- viQtor Wearable Monitoring Device
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2024to 1 Dec 2025
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623EJ
About this study
Official title: 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.
Read the 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.
- Conditions
- Monitoring, Post-operative Monitoring, Patient Safety, Healthcare Technology Implementation, Contiuous Vital Signs Monitoring
- Being tested
- viQtor Wearable Monitoring Device
- Keywords
- Continuous monitoring, Post-operative care, Vital signs, Healthcare technology, Wearable medical device, viQtor solution, Remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viQtor Wearable Monitoring DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: viQtor Wearable Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Oct 2024
- Primary completion31 Jul 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ephrahim Jerry, Catharina Ziekenhuis Eindhoven
- Investigators
- Simon S.W. Nienhuijs, Dr. PHD., Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574867
- Sponsor's protocol ID
- NL. REQUEST
- Acronym
- REQUEST
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 41672938Jerry 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.
PubMed 40608408
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REQUEST - RemotE Monitoring by viQtor Upon Implementation on a Surgical departmenT
- ClinicalTrials.gov ID
- NCT06574867
- Acronym / sponsor ID
- REQUEST / NL. REQUEST
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients Monitored with viQtor | – | Device: viQtor Wearable Monitoring DeviceThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| viQtor Wearable Monitoring DeviceThe 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. | Device | Surgical Patients Monitored with viQtor |
Primary outcome
Usability of the viQtor Monitoring Solution
Time frame: 8 months
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.
3 secondary outcomes
Reduction in Nursing Workload
Time frame: 8 months
Predictive Accuracy of the viQtor Solution
Time frame: 8 months
Implementation Success of the viQtor Solution
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 41672938Jerry 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.
- Derived from this study: PubMed 40608408Jerry 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Monitoring
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon S.W. Nienhuijs, Dr. PHD. principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring and Post-operative Monitoring, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the viQtor Monitoring Solution (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.