Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data. The Sixty device uses diffuse reflectance spectroscopy to measure fluid status. 20 patients will be assessed during the study observation period. 10 patients undergo an observation period of approximately three weeks. The patients will be asked to wear the Sixty device during dialysis and at night throughout the study observation period. Following the completion of this 3 week observation period, an additional 10 patients will wear the Sixty device as per the protocol for 3 weeks. Haemodialysis parameters will be assessed as usual during the study. Bioimpedance measurements will be taken pre and post-dialysis once weekly during the mid-week dialysis session: Patient-reported symptoms related to haemodialysis will be recorded, including symptoms of hypervolaemia and hypovolaemia.
Study Type
OBSERVATIONAL
Enrollment
20
Prototype wearable hydration monitor to be worn by patient during dialysis and at night
Beaumont Hospital
Dublin, Leinster, Ireland
Accuracy of Sixty device versus bioimpedance
The primary endpoint will be to evaluate the accuracy of the Sixty device data in assessing volume in haemodialysis patients compared to bioimpedance Bioimpedance measurements will be performed using the Fresenius Body Composition Monitor (BCM)
Time frame: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session
Fluid removed (mls/ unit of time)
Time frame: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus blood pressure
Blood pressure (mmHg)
Time frame: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis
Weight (kg)
Time frame: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring
Blood volume monitoring: Relative blood volume (%)
Time frame: 3 weeks
Acceptability of Sixty device
The patient's opinion of the acceptability of the Sixty device as assessed by their response to a questionnaire.
Time frame: 3 weeks
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