Back to resultsNon-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation (NIEPCE)
Primary Purpose
Mild Traumatic Injury, Pre-hospital Dispatching, Visioconference
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Visioconference: live visual injury evaluation
Control
Sponsored by
About this trial
This is an interventional diagnostic trial for Mild Traumatic Injury
Eligibility Criteria
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)
Sites / Locations
- Chu of PoitiersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Visioconference: live visual injury evaluation
Standard Procedure
Arm Description
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
Usual management of patients
Outcomes
Primary Outcome Measures
Proportion of patients dispatched elsewhere than to the nearest hospital
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)
Secondary Outcome Measures
Under-triage
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
Over-triage
Over-triage : the proportion of patients initially dispatched to an ED who could have underwent outpatient care
Full Information
NCT ID
NCT05404425
First Posted
May 31, 2022
Last Updated
October 5, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05404425
Brief Title
Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation
Acronym
NIEPCE
Official Title
Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
January 8, 2024 (Anticipated)
Study Completion Date
January 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Injury, Pre-hospital Dispatching, Visioconference
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Visioconference: live visual injury evaluation
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Procedure
Arm Type
Other
Arm Description
Usual management of patients
Intervention Type
Procedure
Intervention Name(s)
Visioconference: live visual injury evaluation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
For patients randomized in the control group, the evaluation is performed by the Emergency Medical Call Center physician only by pone call
Primary Outcome Measure Information:
Title
Proportion of patients dispatched elsewhere than to the nearest hospital
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Under-triage
Description
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
Time Frame
1 year
Title
Over-triage
Description
Over-triage : the proportion of patients initially dispatched to an ED who could have underwent outpatient care
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edouard Magimel-Pelonnier, MD
Phone
0549444444
Ext
+33
Email
edouard.magimel-pelonnier@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Seguin, Clinical research associate
Phone
0549443229
Ext
+33
Email
sabrina.seguin@chu-poitiers.fr
Facility Information:
Facility Name
Chu of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Magimel-Pelonnier, MD
Phone
0549444444
Ext
+33
Email
edouard.magimel-pelonnier@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Sabrina Seguin, Clinical research associate
Phone
0549443229
Ext
+33
Email
sabrina.seguin@chu-poitiers.fr
12. IPD Sharing Statement
Learn more about this trial
Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation
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