Clinical trial NCT03710473: Non-Invasive Blood Pressure Measurement in Critically Ill PAtients Post Cardiosurgical Therapy
Official title: Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study - IMPACT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Hypertension
Keywords: Hypertension
Non-invasive blood pressure Monitoring
Photoplethysmography
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Ava AG
name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2018-10-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients scheduled for cardiac or vascular surgery at the Department of Cardiovascular Surgery of Inselspital, 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement
timeFrame: 24 hours
Secondary outcomes:
measure: Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach
timeFrame: 24 hours
measure: Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Dept of Intensive Care Medicine
Study officials:
affiliation: Dept of Cardiovascular Surgery
name: David Reineke, MD
role: PRINCIPAL_INVESTIGATOR
References: