Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 1:10 AM
Study NCT ID:
NCT05188651
Status:
UNKNOWN
Last Update Posted:
2022-01-12
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D006935', 'term': 'Hypercapnia'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in peripheral oxygen saturation using FFP2/N95 masks', 'timeFrame': 'before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxia', 'Hypercapnia', 'COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': 'aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all kind of dental professionals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dental professionals\n\nExclusion Criteria:\n\n* subjects not signing informed consent\n* subjects unable to wear facemasks due to underlying conditions'}, 'identificationModule': {'nctId': 'NCT05188651', 'briefTitle': 'Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': '4235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dental professionals wearing FFP2/N95 masks', 'interventionNames': ['Behavioral: face masks']}, {'label': 'dental professionals wearing type IIR fluid resistant surgical masks', 'interventionNames': ['Behavioral: face masks']}], 'interventions': [{'name': 'face masks', 'type': 'BEHAVIORAL', 'description': 'wearing face masks', 'armGroupLabels': ['dental professionals wearing FFP2/N95 masks', 'dental professionals wearing type IIR fluid resistant surgical masks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Alessandri Bonetti, DDS', 'role': 'CONTACT'}], 'facility': 'Policlinico Universitario A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Anna Alessandri Bonetti, DDS', 'role': 'CONTACT', 'email': 'anna.alessandribonetti@unicatt.it', 'phone': '+393341413280'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student, Institute of dental clinic and maxillofacial surgery', 'investigatorFullName': 'Anna Alessandri Bonetti', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}