Comparison of a Non Contact Vital Signs Application With Traditional Pulse Oximetry for Heart Rate Measurement

Heart Clinical Trial

— Darwin  

Official title:

Comparison of a Non Contact Vital Signs Application (Darwin Edge rVSM) on a Smartphone With Traditional Pulse Oximetry for Heart Rate Measurement: a Prospective Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439511
• Other study ID #: Darwin
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Hôpital du Valais
• Contact: Sina Grape, MD, MBA
• Phone: 0041276038759
• Email: sina.grape[@]hopitalvs.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to test the accuracy of the Smartphone application Darwin Edge rVSM in measuring heart rate, as compared to traditional pulsoxymetry. The intervention is to look at the smartphone camera for approximately 30 seconds, and after that to compare the heart rate value with that obtained with a recording by pulsoxymetry.

Description:

Participants undergoing a routine perianesthetic consultation at the preanesthetic clinic will be recruited. as a part of routine clinical assessment their heart rate is measured with pulsoxymetry, a non invasive device worn at the fingertip for about 1 minute. this measurement will be compared to the values for heart rate that can be obtaine with the ''Darwin Edge rVSM'' mobile application. this application can be installed on any smartphone. the participant is required to look into the smartphone camera for about 30 seconds. environmental and lighning conditions will be kept stable.

The investigators will do the measurements in 200 participants in order to obtaine values in a population characterized by a variety of phenotypes, in the perioperative setting.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women older than 18 years old presenting to the preanesthetic assessment clinic of Valais Hospital

• Subjects that have signed the informed consent form

Exclusion criteria:

• subjects with damaged/injured skin at the face

• Subjects unable to remain still for 30 seconds

Related Conditions & MeSH terms

• Heart

Intervention

Device:
• Darwin smartphone app
The participant must look into the smartphone camera with the Darwin app for about 30 seconds.
• Pulse oxymetry
Heart rate will be measured with pulsoe oximetry (gold standard)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital du Valais	University of Lausanne Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	accuracy of heart rate measurement	1 minute