Non-Invasive Blood Pressure Measurement in Critically Ill PAtients Post Cardiosurgical Therapy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study - IMPACT

Conditions
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Systemic Hypertension

Intervention / Treatment
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* Diagnostic Test: Optical sensor, Pulse watch


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Optical sensor, Pulse watch|Continuous blood pressure monitoring obtained by a Pulse watch|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement | Statistical comparison of both measures of diastolic blood pressure | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach | 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. | 24 hours | 
| Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment) | To compare the accuracy when applied to photoplethysmographic signals measured at the wrist versus signals measured at the fingertip. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Non-invasive blood pressure Monitoring, Photoplethysmography