Clinical trial NCT06536647: Contactless Assessment of Patient Vital Signs for Triage Using Remote Photoplethysmography in the Emergency Department
Official title: Contactless Assessment of Patient Vital Signs for Triage Using Remote Photoplethysmography in the Emergency Department - 1 Observational Study (CAPTURE-1 Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Photoplethysmography
Vital Signs
Keywords: Photoplethysmography
Vital Signs
Emergency department
Triage
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: PanopticAI
First posted: 2024-08-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a triage category 3 (semi-urgent) to 5 (non-urgent) rating who are clinically stable in the emergency department.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* age \>/= 18 years
* a valid written consent

Exclusion Criteria:

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

Primary outcomes:
measure: The accuracy of patient heart rate estimation
timeFrame: 0 hour post-manual measurement
Secondary outcomes:
measure: The accuracy of patient systolic blood pressure estimation
timeFrame: 0 hour post-manual measurement
measure: The accuracy of patient diastolic blood pressure estimation
timeFrame: 0 hour post-manual measurement
measure: The accuracy of patient respiratory rate estimation
timeFrame: 0 hour post-manual measurement
measure: The accuracy of patient SpO2 estimation
timeFrame: 0 hour post-manual measurement
measure: The accuracy of patient body temperature estimation
timeFrame: 0 hour post-manual measurement
measure: Patient satisfaction
timeFrame: Immediately after the measurements
measure: Patient comfort
timeFrame: Immediately after the measurements
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Accident and Emergency Department, Queen Mary Hospital
state: None Selected
city: Hong Kong
country: Hong Kong
facility: Accident and Emergency Department, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Rex Pui Kin Lam, MBBS, FHKCEM
role: PRINCIPAL_INVESTIGATOR
References: