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

NCT06204822 | Recruiting

• 1 other identifier: 202301108RINC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; SpO2

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

blood pressure measurement

1. 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. 2. First blood pressure measurement is taken, and images and data are recorded for 2 minutes. 3. Participants place both feet on a stool, exerting pressure on the instep (hooking towards the knee) for 1 minute. 4. Maintain the instep pressure and perform the second blood pressure measurement, recording images and data for 2 minutes. 5. Participants place both feet flat on the ground, resting for 1 minute. 6. Third blood pressure measurement is taken, and images and data are recorded for 2 minutes. 7. The examiner adjusts the program settings, and the participant repeats steps 2 to 6 once.

blood oxygen saturation measurement

1. 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. 2. Participants breathe normally while recording images and data for 1 minute. 3. Participants hold their breath until discomfort (aiming for at least 40 seconds) while recording images and data for 1 minute. 4. Participants return to normal breathing, and images and data are recorded for 3 minutes. 5. The experimenter adjusts program settings, and participants repeat steps 2 to 4 once.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age: 18-85 years old
• Install the physiological measurement device on people who do not feel any physical discomfort

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Study Officials

• Huang TZU-JU, M.S.

  NTUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yuan-Hsiang, PhD

CONTACT

(02)2730-3618; linyh@mail.ntust.edu.tw

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: March 6, 2023
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2026
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

TW (1)