Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study - IMPACT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Systemic Hypertension
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement
Time Frame: 24 hours
Statistical comparison of both measures of diastolic blood pressure
Secondary Outcomes
- Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach(24 hours)
- Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment)(24 hours)