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

Physiological Parameters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04660318
• Other study ID #: 2020-A02428-31
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1045
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physiological Parameters
• Plethysmography
• Remote Photoplethysmography Imaging

Intervention

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)
• 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)

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy.	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance of rPPG heart rate readings	Heart rateconcordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG	30-120 seconds.
Primary	Concordance of rPPG respiratory rate readings	respiratory rate concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG	30-120 seconds.
Primary	Concordance of rPPG oxygen saturation readings	oxygen saturation concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG	30-120 seconds.