Dehydration, Hypovolemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBioimpedance sensor
Subjects will wear three bioimpedance sensors throughout their stay at the hospital
Sponsors
Mode Sensors AS
St. Olavs Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in device output from admission to discharge | Day 1 and day of discharge (up to 1 week) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity/specificity of the device for the detection of significant fluid volume changes | 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 |
| Sensitivity/specificity at the three placements | 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 |
| Sensitivity/specificity of different device outputs | 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 |
| Correlation between device output and reference measurements | Day 1 and day of discharge (up to 1 week) | Correlation between changes in device output and reference measurements during the hospital stay |
| User satisfaction among patients | Day 3 | 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. |
Countries
Norway
Contacts
CONTACTSigve N Aas, PhD
CONTACTFrida Bremnes, MSc
STUDY_DIRECTORSigve N Aas, PhD
Mode Sensors AS
Outcome results
None listed