Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT04680858
Status:
UNKNOWN
Last Update Posted:
2020-12-31
First Post:
2020-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-armed study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Communication associated adverse events', 'timeFrame': 'From start to stop of endoscopic procedure', 'description': 'Adverse events arising from impaired communication by COVID-19 protection equipment'}], 'secondaryOutcomes': [{'measure': 'Severe adverse events', 'timeFrame': 'From start to stop of endoscopic procedure', 'description': 'Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment'}, {'measure': 'Subjective Comfort of DECT communication', 'timeFrame': 'From start to stop of endoscopic procedure', 'description': 'Subjectiveley perceived level of comfort using DECT communication during endoscopic procedures rated by numeric rating scale (1-6)'}, {'measure': 'Endoscopic time', 'timeFrame': 'From start to stop of endoscopic procedure', 'description': 'Duration of performed endoscopic procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopy', 'team communication', 'endoscopic procedure', 'COVID-19'], 'conditions': ['Endoscopy', 'Communication']}, 'descriptionModule': {'briefSummary': 'Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.', 'detailedDescription': 'Optimal communication is crucial for team work in high class endoscopy. Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly. Digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances.\n\nMaterials and methods:A prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (EGD, colonoscopy, EUS, ERCP) were randomly assigned (1:1) to a group that was performed with DECT equipped endoscopy team or with standard communication. All examinations were performed under protective equipment. Primary outcome was rate of communication associated adverse events. Secondary outcomes included team subjectively perceived comfort with DECT enhanced communication during endoscopic work, duration of examinations, SAE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Member of staff of the endoscopic team (Doctor, nurse)\n\nExclusion Criteria:\n\n* Deafness\n* significantly impaired hearing'}, 'identificationModule': {'nctId': 'NCT04680858', 'acronym': 'EndoCom', 'briefTitle': 'Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic', 'orgStudyIdInfo': {'id': '122020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Communication', 'description': 'Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset)'}, {'type': 'EXPERIMENTAL', 'label': 'DECT enhanced Communication', 'description': 'Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset)', 'interventionNames': ['Other: DECT']}], 'interventions': [{'name': 'DECT', 'type': 'OTHER', 'description': 'Use of a digital enhanced telecommunication headset for team communication', 'armGroupLabels': ['DECT enhanced Communication']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Mecical clinic 1', 'investigatorFullName': 'Thomas Seufferlein', 'investigatorAffiliation': 'University of Ulm'}}}}