Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 2:03 AM
Study NCT ID:
NCT04660318
Status:
UNKNOWN
Last Update Posted:
2021-06-30
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System l
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1045}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance of rPPG heart rate readings', 'timeFrame': '30-120 seconds.', 'description': 'Heart rateconcordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG'}, {'measure': 'Concordance of rPPG respiratory rate readings', 'timeFrame': '30-120 seconds.', 'description': 'respiratory rate concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG'}, {'measure': 'Concordance of rPPG oxygen saturation readings', 'timeFrame': '30-120 seconds.', 'description': 'oxygen saturation concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plethysmography', 'Remote Photoplethysmography Imaging', 'Physiological Parameters']}, 'referencesModule': {'references': [{'pmid': '34389569', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAlthough 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring a Pulmonary function testing.\n\nExclusion Criteria:\n\n* Patients with stable clinical status.\n* Pregnant woman or Woman of childbearing potential without effective contraception'}, 'identificationModule': {'nctId': 'NCT04660318', 'briefTitle': 'Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System l', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System', 'orgStudyIdInfo': {'id': '2020-A02428-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: remote photoplethysmography for physiological parameters Monitor Readings', 'interventionNames': ['Device: Remote photoplethysmography for physiological parameters']}, {'type': 'OTHER', 'label': 'Control: rstandard acquisition system for physiological parameters Monitor Readings', 'interventionNames': ['Device: standard acquisition system for physiological parameters']}], 'interventions': [{'name': 'Remote photoplethysmography for physiological parameters', 'type': 'DEVICE', 'description': 'physiological parameters will be acquired using the Remote photoplethysmography software simultaneously for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)', 'armGroupLabels': ['Experimental: remote photoplethysmography for physiological parameters Monitor Readings']}, {'name': 'standard acquisition system for physiological parameters', 'type': 'DEVICE', 'description': 'physiological parameters will be acquired using the standard acquisition system for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)', 'armGroupLabels': ['Control: rstandard acquisition system for physiological parameters Monitor Readings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edem ALLADO, MD MSc', 'role': 'CONTACT', 'email': 'e.allado@chru-nancy.fr', 'phone': '+33383155520'}, {'name': 'Edem ALLADO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Régional Universitaire de Nancy.', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}