Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640270
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Performance Evaluation of Lucie for Hydration of Dialysis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the PERFormances of a Bioelectrical Impedancemetry Device Lucie for the Measurement of Hydration Parameters in Patients with Renal Failure a Multicentre Comparative Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERF-LUCIE
Brief Summary:
The main objective of the observatory study is to evaluate the performance of the Lucie medical device for measuring water balance before and after dialysis water overload dry weight in patients with chronic renal failure We will compare the results and performance of the device with the reference device in nephrology the BCM This comparison is based on bioimpedance Bioimpedance is an effective technology for monitoring hydration if used regularly and will give you greater autonomy in your home monitoring It competes with other technologies that we have found to be less effective This is what clinical research is seeking to demonstrate only a clinical study can verify the reliability of this hypothesis The aim is to help Lucie technology mature so that it can detect early signs of fluid overload and ultimately prevent complications or hospitalisation
The process is as follow
After removing their shoes and socks the patient will be invited to step onto the scale
Patient will insert a personal card into the card reader and place his right hand loosely on the LucieTM handle keeping a natural posture
The device will take measurements for 45 seconds under the nurse39s supervision
Patient will go down Lucie and will answer a short form
The device is cleaned after each use For optimum results we recommand patients to keep their feet dry and their hands clean without cream and we recommend them to remove their jewellery to keep their smartphones away from the device to avoid interference and to wear a minimum of nylon-free clothing with empty pockets
In practical terms patients are familiar with monitoring their fluid overload using the Fresinus BCM bathroom scale They already use it as part of their clinical routine when entering and leaving the dialysis room This BCM is used at the start of the dialysis session before the session begins by a nurse trained by the manufacturer in its use he or she knows how to place the electrodes and read the results for status and fluid overload The nurse also takes patientsamp39 usual vital signs blood pressure temperature and notes any incidents during the dialysis session low blood pressure cramps headaches nausea etc in line with standard practice
With Lucie
The process is as follow
After removing their shoes and socks the patient will be invited to step onto the scale
Patient will insert a personal card into the card reader and place his right hand loosely on the LucieTM handle keeping a natural posture
The device will take measurements for 45 seconds under the nurse39s supervision
Patient will go down Lucie and will answer a short form
The device is cleaned after each use For optimum results we recommand patients to keep their feet dry and their hands clean without cream and we recommend them to remove their jewellery to keep their smartphones away from the device to avoid interference and to wear a minimum of nylon-free clothing with empty pockets
In practical terms patients are familiar with monitoring their fluid overload using the Fresinus BCM bathroom scale They already use it as part of their clinical routine when entering and leaving the dialysis room This BCM is used at the start of the dialysis session before the session begins by a nurse trained by the manufacturer in its use he or she knows how to place the electrodes and read the results for status and fluid overload The nurse also takes patientsamp39 usual vital signs blood pressure temperature and notes any incidents during the dialysis session low blood pressure cramps headaches nausea etc in line with standard practice
With Lucie
Detailed Description:
The goal of this observational study is to evaluate the performance of the Lucie medical device for the measurement of pre-dialytic hyperhydration by bioimpedance water volume in L in groups of patients with renal failure compared with the reference device the BCM The main question its aimed to answer is
The primary hypothesis will be to determine the degree of agreement between the BMC measure of pre-dialytic hyperhydration and Lucieampampamp39s water balance volume L
Participants will do the following tasks
Patients weigh themselves on entering the dialysis room to find out their total weight and have it checked by the nurse routine care with a scale that complies with weighing standard NF EN 455012015 and Directive 201431EU
Patients weigh themselves with Lucie and complete a bio-impedance measurement cycle in 45 seconds interventional research
A nurse measures the blood pressure on the cuff CE medical mark standing and lying down and determines the ultrafiltration for the dialysis session to be entered on the machine routine care She records the pre-dialysis information
The nurse performs a bio-impedance measurement with the BCM reference device from Fresenius Medical Care and records measurements of hyperhydration - or overhydration OH - extracellular water ECW total body water TBW the ECWTBW ratio the EI ratio deep breathing test the OHECW ratio interventional research
Patients begin their dialysis session routine care
The nurse records blood pressure standing and lying down after the dialysis session and records post-dialysis information and lists any undesirable events during the dialysis session eg cramps low blood pressure headaches etc
Patients are weighed on leaving the dialysis room to check that they are achieving the prescribed target weight routine care
Patients weigh themselves with Lucie and complete a cycle of bioimpedance measurements in 45 seconds under the control of a nurse interventional research
Patients weigh themselves a second time with the Lucie device and again complete one cycle of bio-impedance measurement in 45 seconds without nurse supervision interventional research the aim of which here is to measure inter-operator reliability
No bio-impedance measurement by the BCM device after the dialysis session given the difficulty of devoting an extra 30 minutes to patients to carry out a second measurement
Lucie device surfaces are cleaned according to the procedure provided
The primary hypothesis will be to determine the degree of agreement between the BMC measure of pre-dialytic hyperhydration and Lucieampampamp39s water balance volume L
Participants will do the following tasks
Patients weigh themselves on entering the dialysis room to find out their total weight and have it checked by the nurse routine care with a scale that complies with weighing standard NF EN 455012015 and Directive 201431EU
Patients weigh themselves with Lucie and complete a bio-impedance measurement cycle in 45 seconds interventional research
A nurse measures the blood pressure on the cuff CE medical mark standing and lying down and determines the ultrafiltration for the dialysis session to be entered on the machine routine care She records the pre-dialysis information
The nurse performs a bio-impedance measurement with the BCM reference device from Fresenius Medical Care and records measurements of hyperhydration - or overhydration OH - extracellular water ECW total body water TBW the ECWTBW ratio the EI ratio deep breathing test the OHECW ratio interventional research
Patients begin their dialysis session routine care
The nurse records blood pressure standing and lying down after the dialysis session and records post-dialysis information and lists any undesirable events during the dialysis session eg cramps low blood pressure headaches etc
Patients are weighed on leaving the dialysis room to check that they are achieving the prescribed target weight routine care
Patients weigh themselves with Lucie and complete a cycle of bioimpedance measurements in 45 seconds under the control of a nurse interventional research
Patients weigh themselves a second time with the Lucie device and again complete one cycle of bio-impedance measurement in 45 seconds without nurse supervision interventional research the aim of which here is to measure inter-operator reliability
No bio-impedance measurement by the BCM device after the dialysis session given the difficulty of devoting an extra 30 minutes to patients to carry out a second measurement
Lucie device surfaces are cleaned according to the procedure provided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None