Simband Data Collectio
- Conditions
- investigation of feasibility non-invasive blood pressure measurement in HDnon-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
* 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
* 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
Name Time Method <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
Name Time Method <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>