Mild Traumatic InjuryNIEPCENCT05404425
Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation
A study testing Visioconference: live visual injury evaluation in people with Mild Traumatic Injury and Pre-hospital Dispatching, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Injury, Pre-hospital Dispatching, Visioconference
- What is being tested?
- Visioconference: live visual injury evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2022to 30 Oct 2023
- 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
- 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
Who cannot join
- severe trauma requiring immediate medical assistance
- trauma associated with head injury, on antiplatelet therapy (APT) or anti-coagulation therapy (ACT)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Visioconference: live visual injury evaluation, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visioconference: live visual injury evaluationProcedure or surgery
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
ControlProcedure or surgery
For patients randomized in the control group, the evaluation is performed by the Emergency Medical Call Center physician only by pone call
| Study group | Role | What they receive |
|---|---|---|
| Visioconference: live visual injury evaluation | Experimental | 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 Receives: Procedure: Visioconference: live visual injury evaluation |
| Standard Procedure | Other | Usual management of patients Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
Over-triage
Over-triage : the proportion of patients initially dispatched to an ED who could have underwent outpatient care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start8 Jul 2022
- Primary completion19 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic InjuryStudies 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
- None (open label)
- Enrolment
- 168 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
- NCT05404425
- Sponsor's protocol ID
- NIEPCE Trial
- Acronym
- NIEPCE
- Status last verified
- Nov 2023
- First submitted
- 31 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation
- ClinicalTrials.gov ID
- NCT05404425
- Acronym / sponsor ID
- NIEPCE / NIEPCE Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 3 Jun 2022 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visioconference: live visual injury evaluation | Experimental | Procedure: Visioconference: live visual injury evaluationFor 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 |
| Standard Procedure | Other | Procedure: ControlUsual management of patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- severe trauma requiring immediate medical assistance
- trauma associated with head injury, on antiplatelet therapy (APT) or anti-coagulation therapy (ACT)
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 |
|---|---|---|
| Visioconference: live visual injury evaluationFor 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 | Procedure or surgery | Visioconference: live visual injury evaluation |
| ControlFor patients randomized in the control group, the evaluation is performed by the Emergency Medical Call Center physician only by pone call | Procedure or surgery | Standard Procedure |
Primary outcome
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)
2 secondary outcomes
Under-triage
Time frame: 1 year
Over-triage
Time frame: 1 year
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 18 Nov 2023.
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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 Visioconference: live visual injury evaluation in people with Mild Traumatic Injury and Pre-hospital Dispatching, 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 5 inclusion and 2 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 18 Nov 2023. 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?
Proportion of patients dispatched elsewhere than to the nearest hospital (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.