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

November 20, 2024 updated by: Hôpital du Valais

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Valais
      • Sion, Valais, Switzerland, 1950
        • Valais Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulse oxymetry
Pulse oxymetry is one of the gold standards for non invasive measurement of heart rate.
Device: Pulse oxymetry
Heart rate will be measured with pulsoe oximetry (gold standard)
Experimental: Smartphone app
This is a new smartphone application which can potentially measure heart rate in less than 30 seconds.
Device: Darwin smartphone app
The participant must look into the smartphone camera with the Darwin app for about 30 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 1 minute
accuracy of heart rate measurement
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital du Valais

Collaborators

University of Lausanne Hospitals

Investigators

  • Study Director: Patrick Schoettker, MD, Lausanne University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Darwin

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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