Systemic Hypertension
Conditions
Keywords
Hypertension, Non-invasive blood pressure Monitoring, Photoplethysmography
Brief summary
The aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist.
Detailed description
Given the prevalence of hypertension in society and the current limitations associated with oscillometric cuffs, the need for a continuous cuffless alternative for blood pressure home monitoring at a global scale is paramount. Such a device would not only improve the global control of blood pressure, but more generally, it could have a larger social impact by improving the comfort and reducing the stress for the clinical management of hypertensive patients. In the present study the investigators seek to investigate, as a primary purpose, to evaluate the accuracy of non-invasive blood pressure measurements via a watch-like optical sensor and compare these to standard monitoring (arterial line).
Interventions
DIAGNOSTIC_TESTOptical sensor, Pulse watch
Continuous blood pressure monitoring obtained by a Pulse watch
Sponsors
Ava AG
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for cardiac or vascular surgery, with presence of a radial arterial line for perioperative management; * Willing and able to provide Informed Consent.
Exclusion criteria
* (Chronic) pace-maker/ defibrillator in situ at study inclusion; * Known severe aortic stenosis (mean gradient \> 40 mmHg, valve area \< 1 cm2); * Rhythmogenic heart disease (resting heart rate \> 120/min) at time of study inclusion; * Emergency patient (i.e. unscheduled OR).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement | 24 hours | Statistical comparison of both measures of diastolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach | 24 hours | To evaluate the influence of the re-calibration time interval (amount of time in-between two consecutive calibrations of the optical devices) on the accuracy of diastolic blood pressure assessment. |
| Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment) | 24 hours | To compare the accuracy when applied to photoplethysmographic signals measured at the wrist versus signals measured at the fingertip. |
Countries
Switzerland
Outcome results
None listed