PhotoplethysmographyCAPTURE-1NCT06536647
Contactless Assessment of Patient Vital Signs for Triage Using Remote Photoplethysmography in the Emergency Department
An observational study of Photoplethysmography and Vital Signs, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Remote photoplethysmography (rPPG) is a camera-based method that enables contactless measurement of variation in light absorbance by haemoglobin as reflected by the changes in skin colour/pixel intensity unperceivable by human eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photoplethysmography, Vital Signs
- What is being tested?
- Contactless measurement of patient vital signs using the VitalsTM system
- How many people
- 1,200 participants
- Where
- 2 sitesHong Kong
- Study dates
- 23 Sep 2024to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a triage category 3 (semi-urgent) to 5 (non-urgent) rating who are clinically stable in the emergency department.
Who may be able to join
- age >/= 18 years
- a valid written consent
Who cannot join
- age < 18 years
- refusal of consent/pre-existing mental illness rending consent impossible
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Accident and Emergency Department, Queen Mary Hospital
Hong Kong, None Selected
Rex Pui Kin Lam, MBBS, FHKCEM, +85260140122, lampkrex@hku.hk
- Recruiting
Accident and Emergency Department, Queen Mary Hospital
Hong Kong
Rex Pui Kin Lam, MBBS, MPH, +85260140122, lampkrex@hku.hk
Rex Lam
About this study
Official title: Contactless Assessment of Patient Vital Signs for Triage Using Remote Photoplethysmography in the Emergency Department - 1 Observational Study (CAPTURE-1 Study)
Remote photoplethysmography (rPPG) is a camera-based method that enables contactless measurement of variation in light absorbance by haemoglobin as reflected by the changes in skin colour/pixel intensity unperceivable by human eyes. Beat-to-beat variation of light-absorbance can be used to estimate the change in the arterial blood volume underneath the skin and different vital signs including the blood pressure, heart rate, respiratory rate and oxygen saturation (SpO2) of the patient.
The investigators propose an observational prospective study to independently evaluate the accuracy of contactless vital sign measurements using a cell phone-based remote photoplethysmography (rPPG) technology. This study will recruit adult patients presenting to the Accident and Emergency Department (A\&E) of Queen Mary Hospital (QMH) between 1 August 2024 and 30 October 2024. The study will be divided into 2 stages. In the initial run-in period, the investigators will collect facial video data from 200 patients to calibrate the VitalsTM system in the A\&E environment. Then, the investigators will evaluate the accuracy of the VitalsTM in estimating vital signs of 1,000 ambulatory patients in the A\&E setting.
Read more
A trained research nurse and research assistant will be deployed from 09:00 to 17:00 on weekdays to screen for eligible patients in the A\&E waiting hall and to recruit patient participants throughout the study period. In this study, the investigators will only recruit triage category 3 (semi-urgent) to 5 (non-urgent) patients who are clinically stable and evaluate the performance of the VitalsTM in a designated room in A\&E. Written informed consent will be obtained from all patient participants after an explanation of the details of the study, including the rationale, benefits and risks of participation.
After informed consent, contactless and manual measurement of patient blood pressure, heart rate, respiratory rate, body temperature and SpO2 will be carried out simultaneously in a designated room in A\&E. A mounted light emitting diode (LED) will be used as the light source. Facial video of the patient participant will be captured using an iPhone, an iPad and a thermal camera placed at around 50 cm from the patient. A reference object for thermal and visual imaging will be placed at the background. Also, ambient temperature and light intensity will be measured.
The patient will be asked to sit down and remain still during video-recording. Manual measurement will be performed simultaneously by a trained research nurse or research assistant using standard hospital device or other medical-grade devices. A software program will be used to log vital sign measurements and recordings simultaneously so that data can be synchronised to reduce variations.
The primary outcome is the accuracy of the VitalsTM platform in estimating patient heart rate measured in intraclass correlation coefficient (ICC). The investigators will also measure of accuracy of the VitalsTM platform in estimating other vital signs, including blood pressure, respiratory rate, SpO2 and body temperature. The investigators will also evaluate patient satisfaction and comfort with the contactless and manual measurement techniques.
The accuracy of contactless measurement will be determined by calculating the ICC from the manual measurement readings as the ground truths. The investigators will also calculate the root mean square error (RMSE) and Pearson correlation between the contactless and manual measurement readings for individual vital signs. Altman Bland plot will be used to evaluate the bias and limits of agreement between two vital sign measurement methods.
- Conditions
- Photoplethysmography, Vital Signs
- Being tested
- Contactless measurement of patient vital signs using the VitalsTM system
- Keywords
- Photoplethysmography, Vital Signs, Emergency department, Triage
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contactless measurement of patient vital signs using the VitalsTM systemDiagnostic test
Contactless measurement of the patient blood pressure, heart rate, respiratory rate, body temperature and SpO2 will be carried out using the VitalsTM platform based on facial video data.
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of patient heart rate estimation
The accuracy of the VitalsTM platform in estimating patient heart rate measured in intraclass correlation coefficient compared to manual heart rate measurement
Measured: 0 hour post-manual measurement
Secondary outcomes (7)
The accuracy of patient systolic blood pressure estimation
The accuracy of the VitalsTM platform in estimating patient non-invasive systolic blood pressure measured in intraclass correlation coefficient compared to manual systolic blood pressure measurement using a non-invasive cuff blood pressure device
Measured: 0 hour post-manual measurement
The accuracy of patient diastolic blood pressure estimation
The accuracy of the VitalsTM platform in estimating patient non-invasive diastolic blood pressure measured in intraclass correlation coefficient compared to manual diastolic blood pressure measurement using a non-invasive cuff blood pressure device
Measured: 0 hour post-manual measurement
The accuracy of patient respiratory rate estimation
The accuracy of the VitalsTM platform in estimating patient respiratory rate pressure measured in intraclass correlation coefficient compared to manual respiratory rate measurement
Measured: 0 hour post-manual measurement
The accuracy of patient SpO2 estimation
The accuracy of the VitalsTM platform in estimating patient SpO2 measured in intraclass correlation coefficient compared to manual SpO2 measurement using a pulse oximetry
Measured: 0 hour post-manual measurement
The accuracy of patient body temperature estimation
The accuracy of the VitalsTM platform in estimating patient body temperature measured in intraclass correlation coefficient compared to manual body temperature measurement using a thermometer
Measured: 0 hour post-manual measurement
Patient satisfaction
Patient satisfaction with the contactless and manual methods measured with a 10 cm visual analogue scale
Measured: Immediately after the measurements
Patient comfort
Patient comfort with the contactless and manual methods measured with a 10 cm visual analogue scale
Measured: Immediately after the measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start23 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoplethysmographyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- PanopticAI
- Responsible party
- Sponsor
- Investigators
- Rex Pui Kin Lam, MBBS, FHKCEM, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536647
- Sponsor's protocol ID
- CAPTURE1
- Acronym
- CAPTURE-1
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Facial video data cannot be shared with other researchers according to the local patient privacy ordinance. Vital signs data from different measurement methods can be shared with other researchers upon reasonable request and after additional approval from the institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contactless Assessment of Patient Vital Signs for Triage Using Remote Photoplethysmography in the Emergency Department - 1 Observational Study (CAPTURE-1 Study)
- ClinicalTrials.gov ID
- NCT06536647
- Acronym / sponsor ID
- CAPTURE-1 / CAPTURE1
- Conditions
- Photoplethysmography, Vital Signs
- Keywords
- Photoplethysmography, Vital Signs, Emergency department, Triage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- PanopticAI
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Aug 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.
Remote photoplethysmography (rPPG) is a camera-based method that enables contactless measurement of variation in light absorbance by haemoglobin as reflected by the changes in skin colour/pixel intensity unperceivable by human eyes. Beat-to-beat variation of light-absorbance can be used to estimate the change in the arterial blood volume underneath the skin and different vital signs including the blood pressure, heart rate, respiratory rate and oxygen saturation (SpO2) of the patient.
The investigators propose an observational prospective study to independently evaluate the accuracy of contactless vital sign measurements using a cell phone-based remote photoplethysmography (rPPG) technology. This study will recruit adult patients presenting to the Accident and Emergency Department (A\&E) of Queen Mary Hospital (QMH) between 1 August 2024 and 30 October 2024. The study will be divided into 2 stages. In the initial run-in period, the investigators will collect facial video data from 200 patients to calibrate the VitalsTM system in the A\&E environment. Then, the investigators will evaluate the accuracy of the VitalsTM in estimating vital signs of 1,000 ambulatory patients in the A\&E setting.
A trained research nurse and research assistant will be deployed from 09:00 to 17:00 on weekdays to screen for eligible patients in the A\&E waiting hall and to recruit patient participants throughout the study period. In this study, the investigators will only recruit triage category 3 (semi-urgent) to 5 (non-urgent) patients who are clinically stable and evaluate the performance of the VitalsTM in a designated room in A\&E. Written informed consent will be obtained from all patient participants after an explanation of the details of the study, including the rationale, benefits and risks of participation.
After informed consent, contactless and manual measurement of patient blood pressure, heart rate, respiratory rate, body temperature and SpO2 will be carried out simultaneously in a designated room in A\&E. A mounted light emitting diode (LED) will be used as the light source. Facial video of the patient participant will be captured using an iPhone, an iPad and a thermal camera placed at around 50 cm from the patient. A reference object for thermal and visual imaging will be placed at the background. Also, ambient temperature and light intensity will be measured.
The patient will be asked to sit down and remain still during video-recording. Manual measurement will be performed simultaneously by a trained research nurse or research assistant using standard hospital device or other medical-grade devices. A software program will be used to log vital sign measurements and recordings simultaneously so that data can be synchronised to reduce variations.
The primary outcome is the accuracy of the VitalsTM platform in estimating patient heart rate measured in intraclass correlation coefficient (ICC). The investigators will also measure of accuracy of the VitalsTM platform in estimating other vital signs, including blood pressure, respiratory rate, SpO2 and body temperature. The investigators will also evaluate patient satisfaction and comfort with the contactless and manual measurement techniques.
The accuracy of contactless measurement will be determined by calculating the ICC from the manual measurement readings as the ground truths. The investigators will also calculate the root mean square error (RMSE) and Pearson correlation between the contactless and manual measurement readings for individual vital signs. Altman Bland plot will be used to evaluate the bias and limits of agreement between two vital sign measurement methods.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a triage category 3 (semi-urgent) to 5 (non-urgent) rating who are clinically stable in the emergency department.
Key inclusion criteria (2 listed)
- age >/= 18 years
- a valid written consent
Key exclusion criteria (2 listed)
- age < 18 years
- refusal of consent/pre-existing mental illness rending consent impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contactless measurement of patient vital signs using the VitalsTM systemContactless measurement of the patient blood pressure, heart rate, respiratory rate, body temperature and SpO2 will be carried out using the VitalsTM platform based on facial video data. | Diagnostic test | – |
Primary outcome
The accuracy of patient heart rate estimation
Time frame: 0 hour post-manual measurement
The accuracy of the VitalsTM platform in estimating patient heart rate measured in intraclass correlation coefficient compared to manual heart rate measurement
7 secondary outcomes
The accuracy of patient systolic blood pressure estimation
Time frame: 0 hour post-manual measurement
The accuracy of patient diastolic blood pressure estimation
Time frame: 0 hour post-manual measurement
The accuracy of patient respiratory rate estimation
Time frame: 0 hour post-manual measurement
The accuracy of patient SpO2 estimation
Time frame: 0 hour post-manual measurement
The accuracy of patient body temperature estimation
Time frame: 0 hour post-manual measurement
Patient satisfaction
Time frame: Immediately after the measurements
Patient comfort
Time frame: Immediately after the measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No. Facial video data cannot be shared with other researchers according to the local patient privacy ordinance. Vital signs data from different measurement methods can be shared with other researchers upon reasonable request and after additional approval from the institutional review board.
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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.
Rex Pui Kin Lam, MBBS, FHKCEM principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Photoplethysmography and Vital Signs, run by The University of Hong Kong at 2 sites in Hong Kong.
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 2 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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 Rex Pui Kin Lam, MBBS, FHKCEM (852 39179413, lampkrex@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of patient heart rate estimation (time frame: 0 hour post-manual measurement). 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 16 Jan 2025.