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

NCT ID: NCT04660318

Last Updated: 2021-06-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

1045 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2022-12-01

Brief Summary

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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

Detailed Description

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Conditions

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Plethysmography Remote Photoplethysmography Imaging Physiological Parameters

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental: remote photoplethysmography for physiological parameters Monitor Readings

Group Type EXPERIMENTAL

Remote photoplethysmography for physiological parameters

Intervention Type DEVICE

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

Control: rstandard acquisition system for physiological parameters Monitor Readings

Group Type OTHER

standard acquisition system for physiological parameters

Intervention Type DEVICE

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

Interventions

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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)

Intervention Type 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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Régional Universitaire de Nancy.

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Edem ALLADO, MD MSc

Role: primary

+33383155520

References

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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.

Reference Type DERIVED
PMID: 34389569 (View on PubMed)

Other Identifiers

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2020-A02428-31

Identifier Type: -

Identifier Source: org_study_id

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