Clinical trial NCT06574867: Evaluation of the viQtor Monitoring Solution on Surgical Wards
Official title: REQUEST - RemotE Monitoring by viQtor Upon Implementation on a Surgical departmenT
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Usability of the viQtor Monitoring Solution
timeFrame: 8 months
Secondary outcomes:
measure: Reduction in Nursing Workload
timeFrame: 8 months
measure: Predictive Accuracy of the viQtor Solution
timeFrame: 8 months
measure: Implementation Success of the viQtor Solution
timeFrame: 8 months
Other outcomes:
measure: Nurse and Physician Adoption of the viQtor Solution
timeFrame: 8 months
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
state: Noord Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Simon S.W. Nienhuijs, Dr. PHD.
role: PRINCIPAL_INVESTIGATOR
References: