Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring (VAMOS)
Validation of a Wearable Bioimpedance Sensor for Non-Invasive Monitoring of Hydration Status
The purpose of the project is to validate the performance of a wearable bioimpedance sensor (Re:Balans®) for monitoring hydration status. The study includes hospitalized patients aged 65 years or older who are admitted to the hospital with suspected dehydration. Data will be collected continuously throughout the hospital stay using one sensor placed on the back, one on the upper arm, and one on the front of the thigh. Sensor measurements will be compared with multiple reference methods for assessing hydration status, including blood tests, body weight and fluid balance charts. Agreement with these reference measures will form the basis for the performance evaluation.
The anticipated benefit of the project is the validation of a novel, user-friendly, and non-invasive tool for hydration monitoring, with the aim of improving patient care, preventing complications, and reducing the need for hospital readmissions.
研究概览
详细说明
The study aims to evaluate how well a wearable bioimpedance sensor (Re:Balans®) tracks changes in hydration status in hospitalized patients. The objective is to validate the sensor's ability to provide continuous, non-invasive monitoring of fluid balance, which may improve the management and treatment of patients at risk of dehydration or fluid overload. Such a solution could also help reduce the need for hospital admissions and in-person follow-up visits.
The investigation is designed as a prospective cohort study in which patients are followed throughout their hospital stay, typically lasting 3-7 days. Participants will wear three sensors, placed on the upper back, upper arm, and anterior thigh. The sensors automatically perform measurements every minute during the study period.
At baseline and during daily follow-up visits, several assessments of hydration status will be performed. These include body weight measurements, blood tests, and whole-body bioimpedance measurements. In a subgroup of patients, ultrasound assessment of the inferior vena cava will also be performed. The combined results from these assessments will serve as reference measures to determine whether the patient's hydration status has changed over time.
At hospital discharge, the assessments are repeated, the sensors are removed, and participants complete a short questionnaire regarding their experience with the device. In addition, fluid balance data (fluid intake and output) will be collected retrospectively from medical records to allow comparison between the sensor measurements and routine clinical monitoring methods. Relevant clinical information obtained as part of standard patient care will also be recorded if considered important for the assessment of hydration status.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Sigve N Aas, PhD
- 电话号码：004741499074
- 邮箱：sigve.aas@modesensors.com
研究联系人备份
- 姓名：Frida Bremnes, MSc
- 邮箱：frida.bremnes@modesensors.com
学习地点
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Trøndelag
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Trondheim、Trøndelag、挪威、7030
- St. Olavs Hospital
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接触：
- Lars P Bjørnsen, PhD
- 电话号码：004793212617
- 邮箱：lars.petter.bache-wiig.bjornsen@stolav.no
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首席研究员：
- Lars P Bjørnsen, PhD
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参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥ 65 years
- Planned fluid management due to presumed dehydration
- Expected duration of hospital stay ≥ 3 days
Exclusion Criteria:
- Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
- Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.
- Scheduled MRI
- Scheduled diathermy
- Breached skin at device application areas (upper back, anterior thigh and upper arm)
- Unconsciousness
- Critically ill (presence of acute organ dysfunction requiring intensive monitoring and management)
- Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
- Incapable of giving informed consent
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Dehydrated patients
The cohort includes individuals 65 years or older admitted to the hospital with dehydration
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Subjects will wear three bioimpedance sensors throughout their stay at the hospital
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Relative change in device output from admission to discharge
大体时间：Day 1 and day of discharge (up to 1 week)
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Relative change in device output from admission to discharge in patients with a confirmed increase in fluid volume, compared with subjects whose hydration status remain stable
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Day 1 and day of discharge (up to 1 week)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sensitivity/specificity of the device for the detection of significant fluid volume changes
大体时间：Once daily during hospital stay, assessed up to 7 days
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Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
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Once daily during hospital stay, assessed up to 7 days
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Sensitivity/specificity at the three placements
大体时间：Once daily during hospital stay, assessed up to 7 days
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Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
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Once daily during hospital stay, assessed up to 7 days
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Sensitivity/specificity of different device outputs
大体时间：Once daily during hospital stay, assessed up to 7 days
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Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
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Once daily during hospital stay, assessed up to 7 days
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Correlation between device output and reference measurements
大体时间：Day 1 and day of discharge (up to 1 week)
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Correlation between changes in device output and reference measurements during the hospital stay
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Day 1 and day of discharge (up to 1 week)
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User satisfaction among patients
大体时间：Day 3
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Subjects will respond to a questionnaire related to user comfort.
The questionnaire uses a 5-point Likert scale ranging from 1 to 5, where lower scores indicate better outcomes and higher scores indicate worse outcomes.
The questionnaire will be filled out on day 3 of the hospital stay.
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Day 3
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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