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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Hypertension
• Intervention / Treatment: Diagnostic test: Optical sensor, Pulse watch

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).

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Dept of Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients scheduled for cardiac or vascular surgery at the Department of Cardiovascular Surgery of Inselspital, Bern.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement; Ava AG
• Investigators: Principal Investigator: David Reineke, MD, Dept of Cardiovascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Photoplethysmography; Non-invasive blood pressure Monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HOPE CT 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No