PlethysmographyNCT04660318
Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System l
A study testing Remote photoplethysmography for physiological parameters and standard acquisition system for physiological parameters in people with Plethysmography and Remote Photoplethysmography Imaging, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plethysmography, Remote Photoplethysmography Imaging, Physiological Parameters
- What is being tested?
- Remote photoplethysmography for physiological parameters and standard acquisition system for physiological parameters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring a Pulmonary function testing.
Who cannot join
- Patients with stable clinical status.
- Pregnant woman or Woman of childbearing potential without effective contraception
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy.
Vandœuvre-lès-Nancy, 54500
Edem ALLADO, MD MSc, +33383155520, e.allado@chru-nancy.fr
Edem ALLADO
About this study
Official title: 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
- Being tested
- Remote photoplethysmography for physiological parameters, standard acquisition system for physiological parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote photoplethysmography for physiological parametersDevice
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 parametersDevice
physiological parameters will be acquired using the standard acquisition system for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: remote photoplethysmography for physiological parameters Monitor Readings | Experimental | Not described Receives: Device: Remote photoplethysmography for physiological parameters |
| Control: rstandard acquisition system for physiological parameters Monitor Readings | Other | Not described Receives: Device: standard acquisition system for physiological parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of rPPG heart rate readings
Heart rateconcordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG
Measured: 30-120 seconds.
Concordance of rPPG respiratory rate readings
respiratory rate concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG
Measured: 30-120 seconds.
Concordance of rPPG oxygen saturation readings
oxygen saturation concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG
Measured: 30-120 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start14 Dec 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PlethysmographyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,045 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660318
- Sponsor's protocol ID
- 2020-A02428-31
- Status last verified
- Jun 2021
- First submitted
- 3 Dec 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34389569
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System
- ClinicalTrials.gov ID
- NCT04660318
- Acronym / sponsor ID
- 2020-A02428-31
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,045 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring a Pulmonary function testing.
Key exclusion criteria (2 listed)
- Patients with stable clinical status.
- Pregnant woman or Woman of childbearing potential without effective contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote photoplethysmography for physiological parametersphysiological parameters will be acquired using the Remote photoplethysmography software simultaneously for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation) | Device | Experimental: remote photoplethysmography for physiological parameters Monitor Readings |
| standard acquisition system for physiological parametersphysiological parameters will be acquired using the standard acquisition system for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation) | Device | Control: rstandard acquisition system for physiological parameters Monitor Readings |
Primary outcome
Concordance of rPPG heart rate readings
Time frame: 30-120 seconds.
Heart rateconcordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 34389569Allado 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centre Hospitalier Régional Universitaire de Nancy.
Vandœuvre-lès-Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote photoplethysmography for physiological parameters and standard acquisition system for physiological parameters in people with Plethysmography and Remote Photoplethysmography Imaging, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of rPPG heart rate readings (time frame: 30-120 seconds.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04660318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.