- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404425
Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation (NIEPCE)
November 16, 2023 updated by: Poitiers University Hospital
Photography teletransmission allow a better and optimized dispatching of patients calling an Emergency Medical Call Center (EMCC) for a mild traumatic injury.
It has previously been studied for patients to whom an ambulance was sent and therefore presumed to be older or with co-morbidities.
The present trial aim to evaluate in the general population, the effect of a smartphone-mediated visioconference in the dispatching of patients calling an EMCC for mild traumatic injury.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Poitiers, France, 86021
- CHU of POITIERS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- adult patients (≥18 years of age),
- free of will (not under any guardianship or liberty privation),
- suffering from Mild Traumatic Injury,
- availability of a smartphone with internet connection for the patients or witness,
- consenting to participate in the study
Exclusion Criteria:
- severe trauma requiring immediate medical assistance
- trauma associated with head injury, on antiplatelet therapy (APT) or anti-coagulation therapy (ACT)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visioconference: live visual injury evaluation
For patients randomized in the intervention group, a live visual evaluation of the injury is performed by the Emergency Medical Call Center physician using a dedicated, secure smartphone app
|
For patients randomized in the intervention group, a live visual evaluation of the injury is performed by the Emergency Medical Call Center physician using a dedicated, secure smartphone app
|
|
Other: Standard Procedure
Usual management of patients
|
For patients randomized in the control group, the evaluation is performed by the Emergency Medical Call Center physician only by pone call
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients dispatched elsewhere than to the nearest hospital
Time Frame: 1 year
|
Proportion of patients dispatched elsewhere than to the nearest hospital (left at home for outpatient care / referred to a higher-level hospital / handled by MICA for advanced pre-hospital medical care)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Under-triage
Time Frame: 1 year
|
Under-triage : the proportion of patients initially left at home for outpatient care who had to visit an ED within the 10 following days for care related to the initial traumatic injury
|
1 year
|
|
Over-triage
Time Frame: 1 year
|
Over-triage : the proportion of patients initially dispatched to an ED who could have underwent outpatient care
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2022
Primary Completion (Actual)
October 19, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
May 31, 2022
First Submitted That Met QC Criteria
May 31, 2022
First Posted (Actual)
June 3, 2022
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIEPCE Trial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Traumatic Injury
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompleted
-
Oragenics, Inc.Not yet recruitingMild Traumatic Brain Injury, ConcussionAustralia
-
Michael HarlEnrolling by invitationBrain Injury | Concussion | Mild Traumatic Brain Injury (mTBI)United States
-
McGill University Health Centre/Research Institute...UnknownMild Traumatic Brain Injury; ConcussionCanada, France, Israel
-
ElMindA LtdGE HealthcareCompletedTBI (Traumatic Brain Injury) | Mild Traumatic Brain Injury | Concussion, MildUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityHealth Science Center of Xi'an Jiaotong University; The Second Affiliated Hospital...RecruitingMTBI - Mild Traumatic Brain InjuryChina
-
Perception Dynamics InstituteUniversity of California, San Diego; University of South Alabama; University...Active, not recruitingMTBI - Mild Traumatic Brain InjuryUnited States
-
Henry M. Jackson Foundation for the Advancement...Brooke Army Medical Center; Tripler Army Medical CenterRecruitingMild Traumatic Brain Injury (mTBI)United States
-
Washington University School of MedicineTerminated
-
Centre Hospitalier de DouaiCompletedCompliance, Patient | Mild Brain Traumatic InjuryFrance
Clinical Trials on Visioconference: live visual injury evaluation
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Konya City HospitalCompletedAnterior Cruciate Ligament Injuries | Anxiety | Anterior Cruciate Ligament Reconstruction | KinesiophobiaTurkey (Türkiye)
-
Sándor BeniczkyUniversity Health Network, Toronto; Oslo University Hospital; Aarhus University... and other collaboratorsCompletedEpilepsy | Non-Epileptic Seizure
-
Institut National de la Santé Et de la Recherche...CompletedParkinson's DiseaseFrance
-
University Hospital, LimogesNot yet recruitingRetinitis Pigmentosa Syndrome
-
University Hospital, GrenobleCompletedHealthy VolunteerFrance
-
Centre Hospitalier Intercommunal de Toulon La Seyne...Université de ToulonCompletedChronic Obstructive Pulmonary Disease (COPD)France
-
Oticon MedicalCompletedSensorineural Hearing Loss | Cochlear Hearing LossFrance
-
Alzheimer's Disease Cooperative Study (ADCS)National Institute on Aging (NIA)CompletedMild Cognitive Impairment | Alzheimer's DiseaseUnited States
-
Federal University of São PauloCompletedAcute Pain | Contraception