Vital Signs Camera Medical Library

Completed

Conditions: niet-invasieve contactloze meting van hartslag en ademhalingsfrequentie
non-invasive contactless measurement of heart rate and respiratory rate

Registration Number: NL-OMON56074

Lead Sponsor: Philips

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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 & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>•The clinical safety and effectiveness of the non-invasive and contactless<br /><br>measurement of PR and RR by the VSC-MEDlib within the intended use. The<br /><br>effectiveness of the VSC-MEDlib will be presented in RMSE in beats and breaths<br /><br>per minute of the PR and RR respectively and compared to the PR and RR measured<br /><br>with the reference devices. It is expected that the 95% upper confidence limit<br /><br>of the RMSE will be <= 3 BPM for PR and RR measured by VSC-MEDlib compared to<br /><br>the reference devices. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Exploratory Endpoint:<br /><br>•The clinical safety and effectiveness of the non-invasive and contactless<br /><br>measurement of PR and RR by the VSC-MEDlib during suboptimal circumstances<br /><br>(outside the scope of the intended use).<br /><br>•Availability of the non-invasive and contactless measurement of PR and RR by<br /><br>the VSC-MEDlib within the intended use and during suboptimal circumstances.<br /><br>Availability is the percentage of valid measurements from the VSC-MEDlib: 100%<br /><br>x [number of valid measurements]/[total number of measurements].<br /><br>•Precision of the non-invasive and contactless measurement of PR and RR by the<br /><br>VSC-MEDlib within the intended use and during suboptimal circumstances.<br /><br>Precision is the percentage of valid measurements from the VSC-MEDlib that<br /><br>differ from the reference device by <= 3 BPM: 100% x [number of valid<br /><br>measurements with Absolute Error <= 3 BPM]/[number valid of measurements].</p><br>