Clinical trial NCT06140433: Vital Signs Camera Study
Official title: Vital Signs Camera Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration Rate
Heart Rate
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2023-11-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical safety and effectiveness VSC-MEDlib according to IFU
timeFrame: 2 hours
measure: Clinical safety and effectiveness VSC-MEDlib according to IFU
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
measure: Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions
timeFrame: 2 hours
measure: Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions
timeFrame: 2 hours
Locations:
city: Eindhoven
country: Netherlands
facility: Philips
state: Noord-Brabant
Study officials:
affiliation: Integrated Technology Solutions
name: Murk Westerterp
role: STUDY_DIRECTOR
References: