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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Sigve N Aas, PhD
- Номер телефона: 004741499074
- Электронная почта: sigve.aas@modesensors.com
Учебное резервное копирование контактов
- Имя: Frida Bremnes, MSc
- Электронная почта: frida.bremnes@modesensors.com
Места учебы
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Trøndelag
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Trondheim, Trøndelag, Норвегия, 7030
- St. Olavs Hospital
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Контакт:
- Lars P Bjørnsen, PhD
- Номер телефона: 004793212617
- Электронная почта: lars.petter.bache-wiig.bjornsen@stolav.no
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Главный следователь:
- Lars P Bjørnsen, PhD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Relative change in device output from admission to discharge
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Sensitivity/specificity of the device for the detection of significant fluid volume changes
Временное ограничение: 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
Временное ограничение: Once daily during hospital stay, assessed up to 7 days
|
Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
|
Once daily during hospital stay, assessed up to 7 days
|
|
Sensitivity/specificity of different device outputs
Временное ограничение: Once daily during hospital stay, assessed up to 7 days
|
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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: Sigve N Aas, PhD, Mode Sensors AS
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CTR0062A VAMOS
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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