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

Consistency evaluation of non-invasive continuous cuffless blood pressure monitoring based on photoplethysmography compared with invasive blood pressure monitoring, mercury sphygmomanometer and 24-hour ambulatory blood pressure measurement

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13366089

Enrollment

300

Registered

2020-01-06

Start date

2019-11-01

Completion date

Unknown

Last updated

2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Circulatory System Hypertension

Interventions

Three hundred participants in multiple centers will be enrolled in this study and divided into 3 parts. There are 100 participants in each part. We record the medical history, routine physical examina

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mean values, standard deviation and 95% confidence interval of systolic blood pressure, mean blood pressure and diastolic blood pressure between the devices.	—

Secondary

Measure	Time frame
1. Pulse rate oxygen saturation of blood 2. Incidence of health issues and equipment failure following the blood pressure measurement: 2.1. Allergy 2.2. Itch 2.3. Equipment out of action or other failures	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026