Observational Study Evaluating the viQtor for Early Detection of Clinical Deterioration in Post-ICU Patients on General Wards
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Development and Validation of a Continuous Early Warning Score (c-EWS) for Detecting Clinical Deterioration in Post-ICU Patients Using the viQtor System
研究概览
简要总结
Rationale Following ICU discharge, intermittent vital sign monitoring may delay timely recognition of clinical deterioration and lead to unnecessary readmissions. This study proposes the use of the viQtor continuous monitoring device to measure pulse rate (PR), respiratory rate (RR), oxygen saturation (SpO2) and the activity index in post-ICU patients on general wards. The primary aim is to develop a continuous Early Warning Score (c-EWS), determine its optimal cut-off values. The secondairy outcome will be a comparison with the Modified Early Warning Score (MEWS). In addition, patient and nurse satisfaction, as well as technical feasibility, will be assessed.
详细描述
Objective(s) Primary: To develop and optimize a c-EWS using viQtor data for early detection of clinical deterioration in post-ICU patients.
Secondary: To evaluate the c-EWS's predictive accuracy relative to MEWS, to assess user satisfaction (patients and nurses), and to determine the technical feasibility of the viQtor device.
Study type This is a single-center prospective observational cohort study at general wards in post-discharge ICU patients.
Study population A single-center prospective observational cohort study will include approximately 180 post-ICU patients and 20 nurses at the Erasmus MC.
Methods Over a four-month period (winter/spring 2024-2025), patients transferred from the ICU to a general ward will wear the viQtor device for up to 5 days. Concurrent standard care involves MEWS measurements three times daily. No clinical decisions will be based on viQtor measurements, ensuring no interference with standard care. The c-EWS will be retrospectively derived and assessed using ROC analyses to determine optimal cut-off values. Comparisons with MEWS will be descriptive. Patient feedback will be collected via a brief questionnaire at discharge, and a semi-structured focus group with participating nurses will provide insights into user experiences.
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
- •Adults ≥18 years of age
- •Written informed consent is obtained from the patient
- •Expected hospitalization time after ICU discharge of 2 days or longer
排除标准
- •The patient is unable to communicate in Dutch or English
- •The patient has an allergy to metal or plastics (as the viQtor device contains these materials)
- •The patient has significant deformities, swelling, irritation, degenerative changes, local infection, ulceration, skin lesions, or edema of the upper arms.
- •The patient has tattoos on both upper arms where the device's PPG sensor would be placed
- •The patient experiences tremors/and or convulsions affecting the upper arm
研究组 & 干预措施
Telemonitoring group
Group wearing the ViQtor telemedicine solution for continuous monitoring
结局指标
主要结局
Development and Validation of a Continuous Early Warning Score (c-EWS) for Detecting Clinical Deterioration in Post-ICU Patients Using the viQtor System
时间窗: From enrollment to the end of monitoring in 5 days
A continuous early warning score (c-EWS) will be developed using the viQtor system to detect clinical deterioration in post-ICU patients on the general ward. Clinical deterioration is defined as an ICU consultation or a Rapid Response Team intervention. The optimal cut-off values for the c-EWS will be identified and evaluated using Receiver Operating Characteristic (ROC) curves and the Area Under the Curve (AUC) values.
次要结局
- Predictive Accuracy of c-EWS vs. MEWS for In-Hospital Cardiac Arrest, ICU Readmission, and Hospital Mortality(From enrollment to the end of monitoring (maximum 5 days).)
- Patient Acceptability of the viQtor System: Likert Questionnaire Results(end of monitoring after 5 days.)
- Predictive Accuracy of c-EWS vs. MEWS for ICU Consultation or Rapid Response Team Intervention(5 days)
- Nurse Perspectives on the viQtor System: Thematic Analysis of Focus Group Results(At the end of the inclusion period)
- Predictive Accuracy of c-EWS in Detecting Clinical Deterioration Within 8 Hours of an Event(From enrollment to the end of monitoring (maximum 5 days).)
研究者
Michael Cornelis van Herwerden
Principal Investigator
Erasmus Medical Center