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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients

NCT04728477

Hypotension

COMPLETED

Non-invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis

NCT03049709

Arterial Hypertension Healthy Control Coronary Heart Disease +1 more

COMPLETED

Invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis

NCT03046264

Arterial Hypertension Coronary Heart Disease

COMPLETED

Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements

NCT03837769

Blood Pressure

COMPLETED NA

Optical System to Continuously Measure Arterial Blood Pressure

NCT02651558

Blood Pressure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optical sensor, Pulse watch

Continuous blood pressure monitoring obtained by a Pulse watch

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No