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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; SpO2

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Lin Yuan-Hsiang, PhD; Phone Number: (02)2730-3618; Email: linyh@mail.ntust.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100225
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chou Nai-Kuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A total of 200 subjects from National Taiwan University Hospital and National Taiwan University of Science and Technology are expected to be included.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
blood pressure measurement; Participants sit in a comfortable posture with hands naturally placed on the table or thighs, palms facing up without obstruction, facing the camera lens. Rest for 2 minutes.; First blood pressure measurement is taken, and images and data are recorded for 2 minutes.; Participants place both feet on a stool, exerting pressure on the instep (hooking towards the knee) for 1 minute.; Maintain the instep pressure and perform the second blood pressure measurement, recording images and data for 2 minutes.; Participants place both feet flat on the ground, resting for 1 minute.; Third blood pressure measurement is taken, and images and data are recorded for 2 minutes.; The examiner adjusts the program settings, and the participant repeats steps 2 to 6 once.
blood oxygen saturation measurement; Participants sit in a comfortable posture with both hands placed naturally on the table or thighs, palms facing up without obstruction, and facing the camera lens. They rest for 2 minutes.; Participants breathe normally while recording images and data for 1 minute.; Participants hold their breath until discomfort (aiming for at least 40 seconds) while recording images and data for 1 minute.; Participants return to normal breathing, and images and data are recorded for 3 minutes.; The experimenter adjusts program settings, and participants repeat steps 2 to 4 once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure changes	Use OMRON HEM-7157T to record changes in blood pressure values	10 min
Blood oxygen changes	Use Cntec CMS-50E to record changes in blood pressure values	5 min

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Huang TZU-JU, M.S., NTUST

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): March 6, 2024
• Study Completion (Estimated): March 6, 2026

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202301108RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No