Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System l

June 29, 2021 updated by: Central Hospital, Nancy, France

Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System

Introduced in 1930, photoplethysmography techniques presented the possibility of measuring SpO2 and HR using the absorption of light by the blood to define these signals In recent years, a new approach to photoplethysmography to measure physiological parameters without contact has been developed. This technique, called remote Photoplethysmography Imaging (rPPG), uses the different Red - Green - Blue color spectra at a skin captured by the camera video to determine a plethysmography signal.

Although these systems have been technically valid, they have not been clinically evaluated in a health setting. This clinical trial is to assess parameters measurements by rPPG compared standard acquisition system in real conditions

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1045

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

  • France
      • Vandoeuvre les nancy, France, 54500
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy.
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients requiring a Pulmonary function testing.

Exclusion Criteria:

  • Patients with stable clinical status.
  • Pregnant woman or Woman of childbearing potential without effective contraception

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental: remote photoplethysmography for physiological parameters Monitor Readings
Device: Remote photoplethysmography for physiological parameters
physiological parameters will be acquired using the Remote photoplethysmography software simultaneously for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)
OTHER: Control: rstandard acquisition system for physiological parameters Monitor Readings
Device: standard acquisition system for physiological parameters
physiological parameters will be acquired using the standard acquisition system for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of rPPG heart rate readings
Time Frame: 30-120 seconds.
Heart rateconcordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG
30-120 seconds.
Concordance of rPPG respiratory rate readings
Time Frame: 30-120 seconds.
respiratory rate concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG
30-120 seconds.
Concordance of rPPG oxygen saturation readings
Time Frame: 30-120 seconds.
oxygen saturation concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG
30-120 seconds.

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 14, 2020

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (ACTUAL)

December 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A02428-31

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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