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

NCT ID: NCT06439511

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All participants will have heart rate measurement

1. by pulse oxymetry
2. by a smartphone application
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pulse oxymetry

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

Group Type ACTIVE_COMPARATOR

Pulse oxymetry

Intervention Type DEVICE

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

Smartphone app

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

Group Type EXPERIMENTAL

Darwin smartphone app

Intervention Type DEVICE

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

Interventions

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Darwin smartphone app

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

Intervention Type DEVICE

Pulse oxymetry

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

HĂ´pital du Valais

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Schoettker, MD

Role: STUDY_DIRECTOR

University of Lausanne Hospitals

Locations

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Valais Hospital

Sion, Valais, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Darwin

Identifier Type: -

Identifier Source: org_study_id

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