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

Systemic Hypertension Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710473
• Other study ID #: HOPE CT 1
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: March 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 15, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypertension
• Systemic Hypertension

Intervention

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

Locations

Country	Name	City	State
Switzerland	Inselspital, Dept of Intensive Care Medicine	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Ava AG, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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