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

Completed

• Conditions: Systemic Hypertension

• Registration Number: NCT03710473
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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).

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-18
• Study Start: 2019-04-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-01-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Inselspital, Dept of Intensive Care Medicine; 🇨🇭 Bern, Switzerland