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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sigve N Aas, PhD
- Número de teléfono: 004741499074
- Correo electrónico: sigve.aas@modesensors.com
Copia de seguridad de contactos de estudio
- Nombre: Frida Bremnes, MSc
- Correo electrónico: frida.bremnes@modesensors.com
Ubicaciones de estudio
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Trøndelag
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Trondheim, Trøndelag, Noruega, 7030
- St. Olavs Hospital
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Contacto:
- Lars P Bjørnsen, PhD
- Número de teléfono: 004793212617
- Correo electrónico: lars.petter.bache-wiig.bjornsen@stolav.no
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Investigador principal:
- Lars P Bjørnsen, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Relative change in device output from admission to discharge
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sensitivity/specificity of the device for the detection of significant fluid volume changes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Sigve N Aas, PhD, Mode Sensors AS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CTR0062A VAMOS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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