Clinical trial NCT06204822: Non-contact Blood Pressure and SpO2 Measurement Based on Image Sensor
Official title: Non-contact Blood Pressure and SpO2 Measurement Based on Image Sensor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
SpO2
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood pressure changes
timeFrame: 10 min
measure: Blood oxygen changes
timeFrame: 5 min
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUST
name: Huang TZU-JU, M.S.
role: PRINCIPAL_INVESTIGATOR
References: