Vital Signs Camera Study (VSC)

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.

Study Overview

• Status: Completed
• Conditions: Heart Rate; Respiration Rate
• Intervention / Treatment: Device: VSC-MEDlib

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5656AE
      • Philips

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VSC-MEDlib; SaMD: Data collection study. Software to be applied after data collection.	Device: VSC-MEDlib; VSC-MEDlib will be used for post-processing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Study Director: Murk Westerterp, Integrated Technology Solutions

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IPS-200169-VSCstudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No