Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-04-19 @ 4:18 AM
Study NCT ID:
NCT04778332
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trottinettes Urgences 2019-2020
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'description of traumatic injuries', 'timeFrame': 'during the first 24 hours.', 'description': 'description of traumatic injuries based on the medical record. Categorised by severity and by anatomical localisation.'}, {'measure': 'Arrival mode', 'timeFrame': 'Up to one year', 'description': 'By ambulance or by own means'}, {'measure': 'Timing of arrival', 'timeFrame': 'Baseline', 'description': 'Immediately after the accident or delayed visit.'}, {'measure': 'Accident mechanism', 'timeFrame': 'Baseline', 'description': 'Other party ( Pedestrians hit by the scooter, accident with another) involved or not ( Loss of balance,2 drivers on the e-scooter,'}, {'measure': 'alcohol', 'timeFrame': 'baseline up to 24 hours', 'description': 'Did the driver report to being under the influence of alcohol or not'}, {'measure': 'Hour of admission', 'timeFrame': 'Baseline up to 24 hours', 'description': 'Admission between 7am-6pm; 6pm-11pm or 11pm-7am'}, {'measure': 'Ownership', 'timeFrame': 'Baseline up to 24 hours', 'description': 'E-scooter owned or rented by the patient'}], 'secondaryOutcomes': [{'measure': 'Treatment', 'timeFrame': 'Up to 24 hours', 'description': 'Emergency department or operative room'}, {'measure': 'Paraclinical examination', 'timeFrame': 'Up to 24 hours', 'description': 'radiography, scanner,'}, {'measure': 'orientation', 'timeFrame': 'Up to 24 hours', 'description': 'Intensive care unit, normal hospitalisation, discharge home'}, {'measure': 'Cost of the treatment', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Ambulance, hospitalisation, treatment in the ED or operative room , temporary incapacity for work.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electronic Scooter', 'Helmet', 'Traumatic injury', 'Alcohol Drinking', 'Traffic Accident', 'Emergencies'], 'conditions': ['Traumatic Injury', 'Accidental Injury', 'Alcohol Drinking', 'Traffic Accident', 'Emergencies']}, 'referencesModule': {'references': [{'pmid': '35727343', 'type': 'DERIVED', 'citation': 'Gan-El E, Ngatchou Djomo W, Pascu Ciobanu AM, Kaufman L, Nde Djiele F, Ulrix M, Kreps B, Plumacker A, Malinverni S, Bartiaux M, Youatou Towo P. Risk assessment, consequences, and epidemiology of electric scooter accidents admitted to an emergency department: a prospective observational study. Eur J Trauma Emerg Surg. 2022 Dec;48(6):4847-4855. doi: 10.1007/s00068-022-02019-5. Epub 2022 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to evaluate the risk, consequences and epidemiology of electric scooter accidents admitted to the emergency room at St. Pierre University Hospital.\n\nThis prospective observational study aims to include any patient admitted to the Adult Emergency Department of St.Pierre University Hospital Brussels following an accident related to the use of an electric scooter in order to describe and understand the epidemiology, complications and treatment of injuries associated with this means of transport.\n\nIt is intended to include all accidents occurring in the emergency room during the period from 01/06/2019 to 30/06/2020.', 'detailedDescription': "All patients over the age of 16 years with traumatic injuries due to an accident related to the use of an electric scooter were included in the study.\n\nUpon admission to the Emergency Department, patients over 16 years of age who accepted were included in the study. The objectives of the study were firstly to describe the context and incidence of scooter accidents, and secondly to understand the epidemiology, complications and treatment of injuries associated with this means of transport and finally, to estimate the economic impact assessed by the number of days of post-traumatic work disability, the need for access to more specialised and therefore more expensive care (operating theatre interventions, scanner-type radiological examinations or hospitalisation in intensive care units).\n\nThe data analyzed were based on :\n\n1\\) the time and day of the accident, 2) the time of presentation at the hospital (same day or after the accident), 3) the mechanism of the accident, whether there were one or two people on the scooter, 4) the use or non-use of the protective helmet, 5) the influence of alcohol ; 6) the mode of arrival at the emergency room (type of ambulance or by one's own means); 7) the injury assessment, paraclinical examinations; 8) treatments; 9) hospitalization or not; 10) temporary work interruptions ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the patient presenting at the ED for traumatic lesion following e-sccoter accident', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All patients with traumatic lesion following electric sccoter accident\n* Be able to agree to participate in the study\n\nExclusion Criteria:\n\n* \\< 16 years\n* Unconscious\n* Being unable to agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT04778332', 'briefTitle': 'Trottinettes Urgences 2019-2020', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Risk Assessment, Consequences and Epidemiology of Electric Scooter Accidents Admitted to Emergency Departments.', 'orgStudyIdInfo': {'id': 'Trottinette19-20'}}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pierre YOUATOU TOWO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Saint Pierre'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'After publication all IPD will be made available through researchgate.com profile of backup investigator', 'accessCriteria': 'Acces will be granted to any researcher requesting access through Researchgate.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}