TraumaNiCEPHORENCT04034797
AmbulaNCE Teletransmited PHOtography for Trauma REgulation
A study testing Photography teletransmission and No photo in people with Trauma and Telemedicine, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Telemedicine
- What is being tested?
- Photography teletransmission and No photo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2019to 31 Jul 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency call at SAMU for trauma issue
- Pre-hospital management by private ambulance equipped with teletransmission device
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Trauma, Telemedicine
- Being tested
- Photography teletransmission, No photo
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photography teletransmissionOther
A photography of the trauma is teletransmitted to SAMU's physician
No photoOther
Usual management without photography teletransmission
| Study group | Role | What they receive |
|---|---|---|
| Photo | Experimental | Not described Receives: Other: Photography teletransmission |
| No photo | Active comparator | Not described Receives: Other: No photo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 2 hours
Secondary outcomes (2)
Undertriage
To evaluate the number of patients initially oriented to out-of hospital care that needed to go to emergency department during following days
Measured: 10 days
Overtriage
To evaluate the number of patients initially oriented to in-hospital care when it wasn't necessary
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start29 Apr 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 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 TraumaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034797
- Sponsor's protocol ID
- 2019-A00137-50
- Acronym
- NiCEPHORE
- Status last verified
- Sep 2020
- First submitted
- 27 Mar 2019
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36242052
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AmbulaNCE Teletransmited PHOtography for Trauma REgulation
- ClinicalTrials.gov ID
- NCT04034797
- Acronym / sponsor ID
- NiCEPHORE / 2019-A00137-50
- Conditions
- Trauma, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 26 Jul 2019 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photo | Experimental | Other: Photography teletransmission |
| No photo | Active comparator | Other: No photo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Emergency call at SAMU for trauma issue
- Pre-hospital management by private ambulance equipped with teletransmission device
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photography teletransmissionA photography of the trauma is teletransmitted to SAMU's physician | Other | Photo |
| No photoUsual management without photography teletransmission | Other | No photo |
Primary outcome
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.
2 secondary outcomes
Undertriage
Time frame: 10 days
Overtriage
Time frame: 10 days
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 Feb 2022.
- Derived from this study: PubMed 36242052Magimel-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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photography teletransmission and No photo in people with Trauma and Telemedicine, run by Poitiers University Hospital at 1 site in France.
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 4 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 Feb 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 France. 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?
Impact of Photography on patient orientation (time frame: 1 - 2 hours). 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 NCT04034797, 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 Feb 2022.