MedPath

Clinical application of continuous cuffless blood pressure monitoring based on optically measured changes in light absorption by blood vessels

Not Applicable
Conditions
Hypertension
Circulatory System
Registration Number
ISRCTN13366089
Lead Sponsor
Department of Hypertension & Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
300
Inclusion Criteria

1. Age from 25 to 80 years old
2. Volunteer to participate in this study and sign the informed consent
3. Requiring arterial blood pressure monitoring
4. Distribution of the blood pressure is in accordance with American National Standards Institute (ANSI)/AAMI/ISO standard revision 2013 (ISO 81060–2:2013).

Exclusion Criteria

1. Any persistent arrhythmias and/or atrial fibrillation
2. Upper limb fracture, trauma, infection, arteriovenous fistula, etc. that might impact the blood pressure measurement
3. Pacemaker installed
4. Fingers with nail polish or nail painting
5. Uncooperative participants with a disordered PPG curve
6. The other cases that the investigators determine to be unsuitable for participation in the study

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean values, standard deviation and 95% confidence interval of systolic blood pressure, mean blood pressure and diastolic blood pressure between the devices.
Secondary Outcome Measures
NameTimeMethod
<br> 1. Pulse rate oxygen saturation of blood<br> 2. Incidence of health issues and equipment failure following the blood pressure measurement:<br> 2.1. Allergy<br> 2.2. Itch<br> 2.3. Equipment out of action or other failures<br>
© Copyright 2025. All Rights Reserved by MedPath