AmbulaNCE Teletransmited PHOtography for Trauma REgulation (NiCEPHORE)
Primary Purpose
Trauma, Telemedicine
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Photography teletransmission
No photo
Sponsored by
About this trial
This is an interventional diagnostic trial for Trauma
Eligibility Criteria
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
Sites / Locations
- CHU Poitiers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Photo
No photo
Arm Description
Outcomes
Primary Outcome Measures
Impact of Photography on patient orientation
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.
Secondary Outcome Measures
Undertriage
To evaluate the number of patients initially oriented to out-of hospital care that needed to go to emergency department during following days
Overtriage
To evaluate the number of patients initially oriented to in-hospital care when it wasn't necessary
Full Information
NCT ID
NCT04034797
First Posted
March 27, 2019
Last Updated
February 18, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04034797
Brief Title
AmbulaNCE Teletransmited PHOtography for Trauma REgulation
Acronym
NiCEPHORE
Official Title
AmbulaNCE Teletransmited PHOtography for Trauma REgulation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Telemedicine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photo
Arm Type
Experimental
Arm Title
No photo
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Photography teletransmission
Intervention Description
A photography of the trauma is teletransmitted to SAMU's physician
Intervention Type
Other
Intervention Name(s)
No photo
Intervention Description
Usual management without photography teletransmission
Primary Outcome Measure Information:
Title
Impact of Photography on patient orientation
Description
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.
Time Frame
1 - 2 hours
Secondary Outcome Measure Information:
Title
Undertriage
Description
To evaluate the number of patients initially oriented to out-of hospital care that needed to go to emergency department during following days
Time Frame
10 days
Title
Overtriage
Description
To evaluate the number of patients initially oriented to in-hospital care when it wasn't necessary
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
State/Province
Aquitaine
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36242052
Citation
Magimel-Pelonnier E, Marjanovic N, Couvreur R, Drugeon B, Mimoz O, Guenezan J. Photography tele-transmission by regular ambulance staff for the management of mild traumatic injury: the NiCEPHORE randomised-controlled trial. Scand J Trauma Resusc Emerg Med. 2022 Oct 14;30(1):53. doi: 10.1186/s13049-022-01026-0.
Results Reference
derived
Learn more about this trial
AmbulaNCE Teletransmited PHOtography for Trauma REgulation
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