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NCT Number: NCT06536647

Contactless Assessment of Patient Vital Signs for Triage Using Remote Photoplethysmography in the Emergency Department

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Accident and Emergency Department, Queen Mary Hospital, Hong Kong, None Selected

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >/= 18 years
  • a valid written consent

Exclusion criteria

  • age < 18 years
  • refusal of consent/pre-existing mental illness rending consent impossible

Treatment and study plan

Contactless measurement of patient vital signs using the VitalsTM system

Diagnostic 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. The accuracy of patient systolic blood pressure estimation

    Time frame: 0 hour post-manual measurement

    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

  2. The accuracy of patient diastolic blood pressure estimation

    Time frame: 0 hour post-manual measurement

    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

  3. The accuracy of patient respiratory rate estimation

    Time frame: 0 hour post-manual measurement

    The accuracy of the VitalsTM platform in estimating patient respiratory rate pressure measured in intraclass correlation coefficient compared to manual respiratory rate measurement

  4. The accuracy of patient SpO2 estimation

    Time frame: 0 hour post-manual measurement

    The accuracy of the VitalsTM platform in estimating patient SpO2 measured in intraclass correlation coefficient compared to manual SpO2 measurement using a pulse oximetry

  5. The accuracy of patient body temperature estimation

    Time frame: 0 hour post-manual measurement

    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

  6. Patient satisfaction

    Time frame: Immediately after the measurements

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

  7. Patient comfort

    Time frame: Immediately after the measurements

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rex Pui Kin Lam, MBBS, FHKCEM

CONTACT

[email protected]

852 39179413

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • PanopticAI

Registry information

Official study title

Contactless Assessment of Patient Vital Signs for Triage Using Remote Photoplethysmography in the Emergency Department - 1 Observational Study (CAPTURE-1 Study)

Acronym: CAPTURE-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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