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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Rex Pui Kin Lam, MBBS, FHKCEM contact

852 39179413

lampkrex@hku.hk

Hong Kong2 sites, 2 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

    Recruiting

Other trials in Hong Kong

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.

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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Patient satisfaction

    Patient satisfaction with the contactless and manual methods measured with a 10 cm visual analogue scale

    Measured: Immediately after the measurements

  7. 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.

  1. First posted5 Aug 2024
  2. Study start23 Sep 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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.

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.

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