Vital Signs Camera Study

Heart Rate Clinical Trial

— VSC  

Official title:

Vital Signs Camera Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06140433
• Other study ID #: IPS-200169-VSCstudy
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: Maarten de Haan
• Phone: +31(0)651954907
• Email: maarten.de.haan[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a single center, prospective clinical investigation which is balanced for gender, age, Body Mass Index (BMI) and skin color. Simultaneous measurements of PR and RR on study participants will be collected in conditions described in IFU and various suboptimal conditions. The study participants will be recorded with the VSC demo app (together with a compatible camera and computing hardware) and reference devices. PR and RR data to be collected by the VSC demo app, will be post-processed after the clinical investigation and compared with the reference devices. Persons who are willing to participate will be asked to provide their consent. Primary objective: • To assess the clinical safety and effectiveness of Pulse Rate (PR) and Respiration Rate (RR) measured with the VSC-MEDlib within the intended use compared to the gold-standard reference devices. Exploratory objective: • To assess the clinical safety and effectiveness of Pulse Rate and Respiration Rate measured with the VSC-MEDlib during suboptimal circumstances (outside the scope of the intended use), compared to the gold-standard reference devices.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persons with ASA I or II classification
• Adult population (age >18 years old)
• BMI = 18 - = 40 kg/m2
• Able to intensively exercise for 10 minutes
• Persons willing to give informed consent
• Willingness to have vital signs measured by a medical mobile application
• Willingness to follow study protocol (e.g., put on sunglasses, facial make-up, medical face-mask and sitting still up to 2 minutes)

Exclusion Criteria:

• Vulnerable populations (e.g., age <18 years old, not able to consent by themselves, or immunecompromised or pregnant women)
• Cardiac arrhythmias (e.g., Atrial Fibrillation, Supraventricular Tachycardia, Ventricular arrhythmia, regular ectopic beats)
• Persons present signs of infection
• Participant has known allergic reactions to make-up and/or make-up remover
• Persons with positive COVID 19 test in last 14 days
• Participant who exhibit irregular or excessive movement such as tremors, tics, shaking and/or shivering
• Participant is Philips employee or their family members residing with this Philips employee.

Related Conditions & MeSH terms

• Heart Rate
• Respiration Rate

Intervention

Device:
• VSC-MEDlib
VSC-MEDlib will be used for post-processing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions	Safety and clinical effectiveness during suboptimal conditions, in RMSE, availability, and precision of the non-invasive and contactless measurement of RR by the VSCMEDlib.	2 hours
Other	Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions	Safety and clinical effectiveness during suboptimal conditions, in RMSE, availability, and precision of the non-invasive and contactless measurement of PR by the VSCMEDlib.	2 hours
Primary	Clinical safety and effectiveness VSC-MEDlib according to IFU	Clinical safety and effectiveness of the non-invasive and contactless measurement RR by the VSC-MEDlib within the intended use.	2 hours
Primary	Clinical safety and effectiveness VSC-MEDlib according to IFU	Clinical safety and effectiveness of the non-invasive and contactless measurement of PR by the VSC-MEDlib within the intended use.	2 hours