Blood pressure Blood pressure
Conditions
Interventions
The Ninox prototype device, which measures SPG and PPG signals at the finger tip.
Sponsors
Stichting imec Nederland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for all participants:=18 years oldWilling and able to provide voluntary, written informed consent. Having sufficient knowledge of Dutch or English language to understand the subject information sheetNot connected to an external or implanted electrical stimulator (e.g. a pacemaker – exclusion due to possible signal interference)No known cardiac arrhythmiasNo use of medication associated with skin photosensitivityNo known allergy or hypersensitivity to ECG skin electrodes[EM1] [EM2] No skin damage at intended electrode placement sites (chest or abdomen) or open wounds on the finger to be measured Inclusion criteria for participant group I at IMEC-NL:For Subgroup B: being available for multiple (2-6) sessions, in a time span of 14 days. Inclusion criteria for participant group II at MMC:a pregnancy between 23 and 37 weeks of gestationhospitalized at the Obstetric High Care or delivery ward at MMC, VeldhovenPatients may be hospitalized for reasons of e.g. partus prematurus imminens (PPI), pre-eclampsia (PE), HELLP syndrome, pregnancy induced hypertension (PIH), fetal growth restriction (FGR), fetal distress, vaginal blood loss, fetal congenital anomalies.Inclusion criteria for participant group III at Anna hospital:Being seen by a health professional at the internal medicine department of the Anna Hospital in Geldrop.Hypertension blood pressure group: with a SBP > 140 mmHg and a DBP > 90 mmHg.Hypotension blood pressure group: with a SBP < 90 mmHg and a DBP < 60 mmHg.Not known of having severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or currently on renal replacement therapy (i.e., hemodialysis or peritoneal dialysis)No known diagnosis of dementia, psychosis as indicated in the electronic health recordNo known life expectancy <1 year, for instance in terminal cancer or NYHA III or IV heart failure
Exclusion criteria
Exclusion criteria: - Have an arm circumference of <22cm or >42cm. This is due to the suitability of the cuff, and will be checked at the first visit. - Have a difference of >10 mmHg systolic or >10mmHg diastolic of the blood pressure between the left and right arm. This will be checked at the first visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter are the systolic and diastolic blood pressure errors, from the blood pressure model compared to the reference blood pressure. These errors will be evaluated separately for the pregnant population as well. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are: - The error of the blood pressure change w.r.t. the first session (model compared to reference). - Signal quality and reproducibility of SPG measurements across different demographics - SPG characteristics related to cardiovascular statusOther parameters: - Medical history and medication related to blood pressure | — |
Countries
Netherlands
Contacts
Public ContactE.J. Maas
Stichting imec Nederland
Outcome results
None listed