- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04034797
AmbulaNCE Teletransmited PHOtography for Trauma REgulation (NiCEPHORE)
Physicians in charge of medical regulation within French SAMU have to take difficult decisions regarding patient's orientation (in or out-of hospital care) but suffer from lack of information. Such information usually consist in a simple phone conversation without any visual information. Visual assesment of the situation would be of great help, especially for traumatized patients.
Private Ambulance societies all over territory in charge of SAMU 86 now work with teletransmission devices allowing photography transmission.
The objective of the study is to determine if routine use of teletransmitted photography help SAMU 86's physians for a better orientation of non-severe traumatized patients, especially by avoiding unnecessary transportations to Emergency Departments.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aquitaine
-
Poitiers, Aquitaine, France, 86000
- CHU Poitiers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Emergency call at SAMU for trauma issue
- Pre-hospital management by private ambulance equipped with teletransmission device
Exclusion Criteria:
- Severe trauma with need of a pre-hospital emergency medical team
- Traffic accident
- Head trauma associated with anticoagulant therapy or platelet antiagregant therapy
- Pre-hospital management by firefighters
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Photo
|
A photography of the trauma is teletransmitted to SAMU's physician
|
Active Comparator: No photo
|
Usual management without photography teletransmission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Photography on patient orientation
Time Frame: 1 - 2 hours
|
Number of patient dispatched anywhere else than the local hospital after ambulance assesement. Either the patient was dispatched to a higher level hospital (i.e. if the local hospital doesn't provide surgical facility when the patient needs it) or he was leaved at home and oriented to a general practitioner. |
1 - 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Undertriage
Time Frame: 10 days
|
To evaluate the number of patients initially oriented to out-of hospital care that needed to go to emergency department during following days
|
10 days
|
Overtriage
Time Frame: 10 days
|
To evaluate the number of patients initially oriented to in-hospital care when it wasn't necessary
|
10 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A00137-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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