- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04778332
Trottinettes Urgences 2019-2020
Risk Assessment, Consequences and Epidemiology of Electric Scooter Accidents Admitted to Emergency Departments.
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.
This 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.
It is intended to include all accidents occurring in the emergency room during the period from 01/06/2019 to 30/06/2020.
Visão geral do estudo
Status
Descrição detalhada
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.
Upon 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).
The data analyzed were based on :
1) 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 .
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Bruxelles, Bélgica, 1000
- CHU Saint-Pierre
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion criteria:
- All patients with traumatic lesion following electric sccoter accident
- Be able to agree to participate in the study
Exclusion Criteria:
- < 16 years
- Unconscious
- Being unable to agree to participate in the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
description of traumatic injuries
Prazo: during the first 24 hours.
|
description of traumatic injuries based on the medical record.
Categorised by severity and by anatomical localisation.
|
during the first 24 hours.
|
Arrival mode
Prazo: Up to one year
|
By ambulance or by own means
|
Up to one year
|
Timing of arrival
Prazo: Baseline
|
Immediately after the accident or delayed visit.
|
Baseline
|
Accident mechanism
Prazo: Baseline
|
Other party ( Pedestrians hit by the scooter, accident with another) involved or not ( Loss of balance,2 drivers on the e-scooter,
|
Baseline
|
alcohol
Prazo: baseline up to 24 hours
|
Did the driver report to being under the influence of alcohol or not
|
baseline up to 24 hours
|
Hour of admission
Prazo: Baseline up to 24 hours
|
Admission between 7am-6pm; 6pm-11pm or 11pm-7am
|
Baseline up to 24 hours
|
Ownership
Prazo: Baseline up to 24 hours
|
E-scooter owned or rented by the patient
|
Baseline up to 24 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Treatment
Prazo: Up to 24 hours
|
Emergency department or operative room
|
Up to 24 hours
|
Paraclinical examination
Prazo: Up to 24 hours
|
radiography, scanner,
|
Up to 24 hours
|
orientation
Prazo: Up to 24 hours
|
Intensive care unit, normal hospitalisation, discharge home
|
Up to 24 hours
|
Cost of the treatment
Prazo: Through study completion, an average of 1 year
|
Ambulance, hospitalisation, treatment in the ED or operative room , temporary incapacity for work.
|
Through study completion, an average of 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pierre YOUATOU TOWO, Centre Hospitalier Universitaire Saint Pierre
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Trottinette19-20
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .