Traumatic InjuryNCT04778332
Trottinettes Urgences 2019-2020
An observational study of Traumatic Injury and Accidental Injury, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Injury, Accidental Injury, Alcohol Drinking
- How many people
- 170 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2019to 31 Mar 2021
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patient presenting at the ED for traumatic lesion following e-sccoter accident
Who may be able to join
- All patients with traumatic lesion following electric sccoter accident
- Be able to agree to participate in the study
Who cannot join
- < 16 years
- Unconscious
- Being unable to agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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 :
- 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 .
- Keywords
- Electronic Scooter, Helmet, Traumatic injury, Alcohol Drinking, Traffic Accident, Emergencies
- Medical subject headings
- Wounds and Injuries, Accidental Injuries, Alcohol Drinking, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
description of traumatic injuries
description of traumatic injuries based on the medical record. Categorised by severity and by anatomical localisation.
Measured: during the first 24 hours.
Arrival mode
By ambulance or by own means
Measured: Up to one year
Timing of arrival
Immediately after the accident or delayed visit.
Measured: Baseline
Accident mechanism
Other party ( Pedestrians hit by the scooter, accident with another) involved or not ( Loss of balance,2 drivers on the e-scooter,
Measured: Baseline
alcohol
Did the driver report to being under the influence of alcohol or not
Measured: baseline up to 24 hours
Hour of admission
Admission between 7am-6pm; 6pm-11pm or 11pm-7am
Measured: Baseline up to 24 hours
Ownership
E-scooter owned or rented by the patient
Measured: Baseline up to 24 hours
Secondary outcomes (4)
Treatment
Emergency department or operative room
Measured: Up to 24 hours
Paraclinical examination
radiography, scanner,
Measured: Up to 24 hours
orientation
Intensive care unit, normal hospitalisation, discharge home
Measured: Up to 24 hours
Cost of the treatment
Ambulance, hospitalisation, treatment in the ED or operative room , temporary incapacity for work.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Jun 2019
- Primary completion30 Jun 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre YOUATOU TOWO, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778332
- Sponsor's protocol ID
- Trottinette19-20
- Status last verified
- Apr 2022
- First submitted
- 18 Feb 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication all IPD will be made available through researchgate.com profile of backup investigator
Publications
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.
PubMed 35727343
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment, Consequences and Epidemiology of Electric Scooter Accidents Admitted to Emergency Departments.
- ClinicalTrials.gov ID
- NCT04778332
- Acronym / sponsor ID
- Trottinette19-20
- Keywords
- Electronic Scooter, Helmet, Traumatic injury, Alcohol Drinking, Traffic Accident, Emergencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 :
- 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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patient presenting at the ED for traumatic lesion following e-sccoter accident
Key inclusion criteria (2 listed)
- All patients with traumatic lesion following electric sccoter accident
- Be able to agree to participate in the study
Key exclusion criteria (3 listed)
- < 16 years
- Unconscious
- Being unable to agree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
description of traumatic injuries
Time frame: during the first 24 hours.
description of traumatic injuries based on the medical record. Categorised by severity and by anatomical localisation.
Arrival mode
Time frame: Up to one year
By ambulance or by own means
Timing of arrival
Time frame: Baseline
Immediately after the accident or delayed visit.
Accident mechanism
Time frame: Baseline
Other party ( Pedestrians hit by the scooter, accident with another) involved or not ( Loss of balance,2 drivers on the e-scooter,
alcohol
Time frame: baseline up to 24 hours
Did the driver report to being under the influence of alcohol or not
Hour of admission
Time frame: Baseline up to 24 hours
Admission between 7am-6pm; 6pm-11pm or 11pm-7am
Ownership
Time frame: Baseline up to 24 hours
E-scooter owned or rented by the patient
4 secondary outcomes
Treatment
Time frame: Up to 24 hours
Paraclinical examination
Time frame: Up to 24 hours
orientation
Time frame: Up to 24 hours
Cost of the treatment
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 35727343Gan-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.
- Individual participant dataSharing planned: Yes. After publication all IPD will be made available through researchgate.com profile of backup investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre YOUATOU TOWO principal investigator
Centre Hospitalier Universitaire Saint Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Injury and Accidental Injury, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of traumatic injuries (time frame: during the first 24 hours.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.