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

NCT06439511 | Completed

• 1 other identifier: Darwin
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart

Outcome Measures

Primary Outcomes (1)

• Heart rate

  accuracy of heart rate measurement

  1 minute

Study Arms (2)

Pulse oxymetry

ACTIVE COMPARATOR

Pulse oxymetry is one of the gold standards for non invasive measurement of heart rate.

Device: Pulse oxymetry

Smartphone app

EXPERIMENTAL

This is a new smartphone application which can potentially measure heart rate in less than 30 seconds.

Device: Darwin smartphone app

Interventions

Darwin smartphone app DEVICE

The participant must look into the smartphone camera with the Darwin app for about 30 seconds.

Smartphone app

Pulse oxymetry DEVICE

Heart rate will be measured with pulsoe oximetry (gold standard)

Pulse oxymetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• subjects with damaged/injured skin at the face
• Subjects unable to remain still for 30 seconds

Sponsors & Collaborators

• Hôpital du Valais: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Valais Hospital

Sion, Valais, 1950, Switzerland

Location

Study Officials

• Patrick Schoettker, MD

  University of Lausanne Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will have heart rate measurement 1. by pulse oxymetry 2. by a smartphone application

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 3, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)