Blood PressureNCT06204822
Non-contact Blood Pressure and SpO2 Measurement Based on Image Sensor
An observational study of Blood Pressure and SpO2, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, SpO2
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Mar 2023to 6 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age: 18-85 years old
- Install the physiological measurement device on people who do not feel any physical discomfort
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Chou Nai-Kuan
About this study
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.
Read the 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.
- Conditions
- Blood Pressure, SpO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure changes
Use OMRON HEM-7157T to record changes in blood pressure values
Measured: 10 min
Blood oxygen changes
Use Cntec CMS-50E to record changes in blood pressure values
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start6 Mar 2023
- Primary completion6 Mar 2024 (estimated)
- Study completion6 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang TZU-JU, M.S., Principal investigator, NTUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204822
- Sponsor's protocol ID
- 202301108RINC
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-contact Blood Pressure and SpO2 Measurement Based on Image Sensor
- ClinicalTrials.gov ID
- NCT06204822
- Acronym / sponsor ID
- 202301108RINC
- Conditions
- Blood Pressure, SpO2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 6 Mar 2024 (estimated)
- Study completion
- 6 Mar 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age: 18-85 years old
- Install the physiological measurement device on people who do not feel any physical discomfort
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure changes
Time frame: 10 min
Use OMRON HEM-7157T to record changes in blood pressure values
Blood oxygen changes
Time frame: 5 min
Use Cntec CMS-50E to record changes in blood pressure values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang TZU-JU, M.S. principal investigator
NTUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and SpO2, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Yuan-Hsiang, PhD ((02)2730-3618, linyh@mail.ntust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure changes (time frame: 10 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.