Objective: Gather data on the use of Simband, positioned at the wrist, to estimate BP based on data from Simband*s ECG and PPG sensors, compare these results to the existing cuff-based BP measurements during haemodialysis treatment and apply the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
investigation of feasibility non-invasive blood pressure measurement in HD
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Completion of recording good quality datasets
for 30 patients over 3 consecutive dialysis sessions per patient.
Secondary outcome
Investigating possible correlations with other recorded parameters from the
on-board Simband sensors for their potential to refine the accuracy of blood
pressure readings.
Background summary
Rationale: Simband, a wrist wearable multi-sensor platform, offers potential
for simple non-invasive cuffless blood pressure (BP) measurements, but
comparison to clinical data is needed to confirm practical usability of the
technology. Haemodialysis patients form a group that might specifically benefit
from a cuffless bloodpressure monitor in a wrist watch. At the same time, they
also form a group where comparison of Simband blood pressure readings to the
clinical standard can be done without adding meaningful additional burden to
the existing treatment.
Study objective
Objective: Gather data on the use of Simband, positioned at the wrist, to
estimate BP based on data from Simband*s ECG and PPG sensors, compare these
results to the existing cuff-based BP measurements during haemodialysis
treatment and apply the anonymized recorded data to investigate possible
improvements of accuracy.
Study design
Study design: Observational study.
Study burden and risks
Neither significant risks nor direct immediate benefits are expected for the
participating individual subjects. Additional individual patient burden is
increased frequency of normal reference blood pressure measurement (every 15
min) and wearing a wrist watch device on one wrist (non-fistula arm), combined
with a single adhesive ECG electrode at the other wrist, connected by a
flexible wire. Total duration of the normal dialysis procedure (usual 4 hours)
will be maximally 30 minutes longer. This extra time will be spent on:
* All three sessions, investigative: Fitting the Simband device around the
wrist, start/stop recordings and device retrieval the device after dialysis.
* All three sessions, reference: Additional bioimpedance reference measurement
on the non-fistula arm using a Body Composition Monitor (BCM®, Fresenius
Medical Care, Bad Homburg, Germany). In addition the attachement and wearing of
the PPG finger clip sensor (Nellcor N-200E) during the complete measurement.
* Only first session, reference: Non-invasive arterial stiffness measurement on
neck (carotis) and wrist (radialis) artery at non-fistula side before and after
dialysis (SphygmoCor, AtCor Medical).
Possible benefit on the long term for dialysis patients as a group might be the
realization of a simple wearable blood pressure meter that does not interfere
with normal daily life.
High tech campus 31
Eindhoven 5656 AE
NL
High tech campus 31
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
* Stable ESRD patient on routine haemodialysis
* Age * 18 years
* Informed consent
* Height between 1.50 and 2 meters
* Weight between 50 and 120 kilograms
* BMI between 15 and 35
Exclusion criteria
* Subjects with a known allergy to stainless steel (grade 304) or polyurethane (8400, a synthetic polymer);
* Subjects who are pregnant or likely to become pregnant (very unlikely in ESRD);
* Subjects with any active implantable device, such as a pacemaker, ICD or implanted infusion pump;
* Subjects using medication with phototoxic side effects:
- Tetracyclines
- Doxycycline
- Phenothiazines
- Dacarbazine
- Ketoprofen
- Lomefloxacin (maxaquin) or other fluoroquinolones
This in order to exclude the possibility of local skin irritation problems from prolonged irradiation by LED light.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52553.068.15 |