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Simband Data Collection

Simband Data Collection - Simband datacollectie

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45199
Enrollment
30
Registered
2015-09-02
Start date
2015-11-11
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

investigation of feasibility non-invasive blood pressure measurement in HD non-invasive blood pressure measurement

Interventions

None listed

Sponsors

Imec Nederland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: Completion of recording good quality datasets for 30 patients over 3 consecutive dialysis sessions per patient.

Secondary

MeasureTime frame
Investigating possible correlations with other recorded parameters from the on-board Simband sensors for their potential to refine the accuracy of blood pressure readings.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)