Non-contact Blood Pressure and SpO2 Measurement Based on Image Sensor

Blood Pressure Clinical Trial

Official title:

Non-contact Blood Pressure and SpO2 Measurement Based on Image Sensor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204822
• Other study ID #: 202301108RINC
• Status: Recruiting
• Start date: March 6, 2023
• Est. completion date: March 6, 2026

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Lin Yuan-Hsiang, PhD
• Phone: (02)2730-3618
• Email: linyh[@]mail.ntust.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to develop an automated and real-time non-contact vital sign measurement system using cameras. It will collaborate with physicians from National Taiwan University Hospital to conduct measurements during outpatient visits or hospitalizations. This allows physicians to non-invasively measure multiple vital signs (such as heart rate, blood pressure, and oxygen saturation) upon your entry to the outpatient clinic or hospital. Simultaneously, the measurements will be verified using commercially available contact-based instruments. The research outcomes of this project aim to enhance the convenience, safety, and comfort of vital sign measurements for outpatient visits, hospitalizations, and long-term care in the future.

Description:

The experiment of this project is to use a camera to measure blood pressure, blood oxygen saturation and pulse, record images of the face and hands, and use the image processing algorithm we developed to extract the signals from the images to estimate blood pressure and blood oxygen Concentration and pulse values. The experimental process will be carried out in accordance with the "experimental setup, blood pressure measurement, and blood oxygen saturation measurement" process. At the same time, commercially available measurement instruments will be used to conduct clinical experiments and verification. The experimental setup diagram is shown in Figure 1. Blood pressure and blood pressure The oxygen saturation measurement process is shown in Figure 2. The blood pressure measurement process takes about 10 minutes, and the blood oxygen measurement process takes about 5 minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 6, 2026
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age: 18-85 years old

• Install the physiological measurement device on people who do not feel any physical discomfort

Exclusion Criteria:

• Age > 85 years, age < 18 years

• Patients with arrhythmia

• Those with a history of severe heart disease

• Those who wear makeup on their face (for example: foundation cream, sunscreen lotion, foundation...etc.).

• The body will make involuntary, short-term, rapid or repetitive movements unconsciously, resulting in the inability to control the body to reach a stable and static state. For example: patients with motor-related Tourette Syndrome, etc.

Related Conditions & MeSH terms

• Blood Pressure
• SpO2

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure changes	Use OMRON HEM-7157T to record changes in blood pressure values	10 min
Primary	Blood oxygen changes	Use Cntec CMS-50E to record changes in blood pressure values	5 min