REQUEST - RemotE Monitoring by viQtor Upon Implementation on a Surgical departmenT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Usability of the viQtor Monitoring Solution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: viQtor Wearable Monitoring Device (Device)
结局指标
主要结局
Usability of the viQtor Monitoring Solution
时间窗: 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.
次要结局
- Reduction in Nursing Workload(8 months)
- Predictive Accuracy of the viQtor Solution(8 months)
- Implementation Success of the viQtor Solution(8 months)
研究者
Ephrahim Jerry
Drs.
Catharina Ziekenhuis Eindhoven