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

NCT04660318 | Unknown

• 1 other identifier: 2020-A02428-31
• Study Type: interventional
• Target: 1,045
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Plethysmography; Remote Photoplethysmography Imaging; Physiological Parameters

Outcome Measures

Primary Outcomes (3)

• Concordance of rPPG heart rate readings

  Heart rateconcordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG

  30-120 seconds.

• Concordance of rPPG respiratory rate readings

  respiratory rate concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG

  30-120 seconds.

• Concordance of rPPG oxygen saturation readings

  oxygen saturation concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG

  30-120 seconds.

Study Arms (2)

Experimental: remote photoplethysmography for physiological parameters Monitor Readings

EXPERIMENTAL

Device: Remote photoplethysmography for physiological parameters

Control: rstandard acquisition system for physiological parameters Monitor Readings

OTHER

Device: standard acquisition system for physiological parameters

Interventions

Remote photoplethysmography for physiological parameters DEVICE

physiological parameters will be acquired using the Remote photoplethysmography software simultaneously for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)

Experimental: remote photoplethysmography for physiological parameters Monitor Readings

standard acquisition system for physiological parameters DEVICE

physiological parameters will be acquired using the standard acquisition system for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)

Control: rstandard acquisition system for physiological parameters Monitor Readings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring a Pulmonary function testing.

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy.

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (1)

• Allado E, Poussel M, Moussu A, Saunier V, Bernard Y, Albuisson E, Chenuel B. Innovative measurement of routine physiological variables (heart rate, respiratory rate and oxygen saturation) using a remote photoplethysmography imaging system: a prospective comparative trial protocol. BMJ Open. 2021 Aug 13;11(8):e047896. doi: 10.1136/bmjopen-2020-047896.

  PMID: 34389569 DERIVED

Study Design

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

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: December 14, 2020
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

FR (1)