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Simband Data Collectio

Completed
Conditions
investigation of feasibility non-invasive blood pressure measurement in HD
non-invasive blood pressure measurement
Registration Number
NL-OMON45199
Lead Sponsor
Imec Nederland
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
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.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study parameters/endpoints: Completion of recording good quality datasets<br /><br>for 30 patients over 3 consecutive dialysis sessions per patient. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Investigating possible correlations with other recorded parameters from the<br /><br>on-board Simband sensors for their potential to refine the accuracy of blood<br /><br>pressure readings.</p><br>
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