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

Overview

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.

Full Title of Study: “Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study – IMPACT”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2020

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 Test: Optical sensor, Pulse watch
    • Continuous blood pressure monitoring obtained by a Pulse watch

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach
    • Time Frame: 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)
    • Time Frame: 24 hours
    • To compare the accuracy when applied to photoplethysmographic signals measured at the wrist versus signals measured at the fingertip.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Insel Gruppe AG, University Hospital Bern
  • Collaborator
    • Ava AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Reineke, MD, Principal Investigator, Dept of Cardiovascular Surgery

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