Out-of-hospital SettingVISIODYS-PEDNCT06847997
Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre
A study testing Addition of telemedicine to standard medical dispatching process (Experimental Group) in people with Out-of-hospital Setting and Dyspnea, run by Poitiers University Hospital at 1 site in France.
Trial summary
Dyspnoea is defined as the sensation of difficult or uncomfortable breathing experienced by a patient. It is a significant concern in emergency care, accounting for 8% of calls to the emergency medical call centre (EMCC) and 10% of Emergency department (ED) admissions. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Out-of-hospital Setting, Dyspnea
- What is being tested?
- Addition of telemedicine to standard medical dispatching process (Experimental Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2025to 13 Jul 2026
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 3 months to 5 years
- Call from parent(s) to an EMCC for dyspnea or shortness of breath or difficulty breathing as main complaint
- Parent or witness with a phone/tablet equipped with a camera
- Emergency consent or oral consent given by the holder(s) of parental authority to the physician dispatcher
Who cannot join
- Child in life-saving emergency
- Known absence of a telephone network required for the use of video calls
- Call made by an individual who does not hold parental authority
- Communication difficulties with the holder(s) of parental authority, not allowing for a clear and fair information
- Person not benefiting from a social security scheme or through a third party
- Child who has already participated in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre: the VISIODYS-PED Randomised Controlled Study Protocol
Dyspnoea is defined as the sensation of difficult or uncomfortable breathing experienced by a patient. It is a significant concern in emergency care, accounting for 8% of calls to the emergency medical call centre (EMCC) and 10% of Emergency department (ED) admissions. Among paediatric patients, dyspnoea accounts from 14-27% of ED admissions, exhibiting notable seasonal variation. Approximately 10% of these patients require hospitalisation, and 1-3% of cases progress to respiratory failure. All these patients require a comprehensive clinical examination to accurately identify signs of severity, ensuring the timely initiation of specialized and effective treatment.
In France, patients are encouraged to contact the local EMCC before visiting an ED. Medical dispatchers assess the clinical condition by phone, based on medical history, symptoms and current treatment. Based on this assessment, the medical dispatcher determines the appropriate decision which may include providing medical advice, directing the patient to an ED, or deploying a mobile intensive care unit (MICU). Seven percent of calls to an EMCC involve paediatric cases, with nearly half concerning children under six years of age with hyperthermia and dyspnoea as most complaints, particularly during epidemic periods. The medical assessment of paediatric dyspnoea by EMCC is particularly challenging. The inability of children to articulate their symptoms, coupled with parents difficulty in describing the situation - often exacerbated by anxiety - creates significant obstacles. Furthermore, the absence of a direct observation by the physician adds to the complexity and could lead to an inappropriate triage and management.
Read more
Telemedicine uses communication technologies for remote consultations, electronic record management, and document sharing. It enables real-time visual evaluation, thereby improving diagnostic accuracy and decision-making. While evidence supports its benefits in managing adult dyspnoeic patients, further research is essential to validate its efficacy in paediatric settings, particularly within EMCC.
This study will aim to evaluate the effectiveness of telemedicine within an EMCC and utilising real-time visualization in reducing inappropriate triage of children requiring care for acute dyspnoea.
Read the detailed description
This is a superiority, prospective, individually randomized, open-label and monocentric study.
- Conditions
- Out-of-hospital Setting, Dyspnea
- Being tested
- Addition of telemedicine to standard medical dispatching process (Experimental Group)
- Keywords
- dyspnea, telemedicine, emergency
- Medical subject headings
- Dyspnea, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of telemedicine to standard medical dispatching process (Experimental Group)Other
In the experimental group, the same approach is used, with the addition of telemedicine using video calls. Callers are invited to use their smartphone camera to enable real-time video assessment. The medical dispatcher sends a secure link (via a platform provided by Enovacom, Nomadeec, Bordeaux, France) to the caller's smartphone, allowing video streaming through a secure internet connection. Once the link is validated by the caller, the live video feed from the smartphone camera is transmitted directly to the dispatcher's computer screen, providing a visual evaluation to support clinical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical dispatching process (Control group) | No intervention | The emergency physician dispatcher conducts a standard medical dispatching process. |
| Addition of telemedicine to standard medical dispatching process (Experimental Group) | Experimental | The emergency physician dispatcher conducts a standard medical dispatching process with the addition of telemedicine using video calls. Receives: Other: Addition of telemedicine to standard medical dispatching process (Experimental Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients inaccurately managed
The primary endpoint is the proportion of patients inaccurately managed (over-triage or under-triage)
Over-triage is defined as a situation where a patient is:
- Directed to an ED following the call, but does not require any specific treatment, diagnostic tests, or hospitalisation, within 24h following the primary call, or
- Managed by the deployment of a MICU, despite not requiring specific treatment or transfer to an ED, within 24h following the primary call.
Under-triage is defined as a situation where a patient is kept at home with medical advice or directed to a family practitioner after the primary call AND later dispatched to hospital by a family practitioner or after a second call to an EMCC for dyspnoea, or hospitalised or dead within 24h following the primary call.
Measured: 24 hours
Secondary outcomes (7)
Proportion of patients in over-triage situation
Over-triage is defined as a situation where a patient is: (a) Directed to an ED following the call, but does not require any specific treatment, diagnostic tests, or hospitalisation, within 24h following the primary call, or (b) Managed by the deployment of a MICU, despite not requiring specific treatment or transfer to an ED, within 24h following the primary call.
Measured: 24 hours
Proportion of patients in under-triage situation
Under-triage is defined as a situation where a patient is kept at home with medical advice or directed to a family practitioner after the primary call AND later dispatched to hospital by a family practitioner or after a second call to an EMCC for dyspnoea, or hospitalised or dead within 24h following the primary call.
Measured: 24 hours
Proportion of patients who called a second time the emergency communication center for dyspnea
Measured: 24 hours
Proportion of deceased patients at day 28
Measured: 28 days
Proportion of patients hospitalized within 28 days
Measured: 28 days
Medical decision at the end of the call
Proportion of patients in each situation at the end of the call: medical advice, referred to a non-hospital-based care, dispatched to an emergency department, emergency medical service.
Measured: At the end of the call to emergency communication center
Duration of the call
The duration of the call to emergency communication center, defined as the time between the beginning of the call and the medical decision (in minutes)
Measured: At the end of the call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start30 Mar 2025
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital SettingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Marjanovic, MD PhD, Principal investigator, Poitiers University HospitalErwan Ripley, MD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847997
- Sponsor's protocol ID
- VISIODYS-PED
- Acronym
- VISIODYS-PED
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre: the VISIODYS-PED Randomised Controlled Study Protocol
- ClinicalTrials.gov ID
- NCT06847997
- Acronym / sponsor ID
- VISIODYS-PED / VISIODYS-PED
- Conditions
- Out-of-hospital Setting, Dyspnea
- Keywords
- dyspnea, telemedicine, emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 26 Feb 2025 (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.
Dyspnoea is defined as the sensation of difficult or uncomfortable breathing experienced by a patient. It is a significant concern in emergency care, accounting for 8% of calls to the emergency medical call centre (EMCC) and 10% of Emergency department (ED) admissions. Among paediatric patients, dyspnoea accounts from 14-27% of ED admissions, exhibiting notable seasonal variation. Approximately 10% of these patients require hospitalisation, and 1-3% of cases progress to respiratory failure. All these patients require a comprehensive clinical examination to accurately identify signs of severity, ensuring the timely initiation of specialized and effective treatment.
In France, patients are encouraged to contact the local EMCC before visiting an ED. Medical dispatchers assess the clinical condition by phone, based on medical history, symptoms and current treatment. Based on this assessment, the medical dispatcher determines the appropriate decision which may include providing medical advice, directing the patient to an ED, or deploying a mobile intensive care unit (MICU). Seven percent of calls to an EMCC involve paediatric cases, with nearly half concerning children under six years of age with hyperthermia and dyspnoea as most complaints, particularly during epidemic periods. The medical assessment of paediatric dyspnoea by EMCC is particularly challenging. The inability of children to articulate their symptoms, coupled with parents difficulty in describing the situation - often exacerbated by anxiety - creates significant obstacles. Furthermore, the absence of a direct observation by the physician adds to the complexity and could lead to an inappropriate triage and management.
Telemedicine uses communication technologies for remote consultations, electronic record management, and document sharing. It enables real-time visual evaluation, thereby improving diagnostic accuracy and decision-making. While evidence supports its benefits in managing adult dyspnoeic patients, further research is essential to validate its efficacy in paediatric settings, particularly within EMCC.
This study will aim to evaluate the effectiveness of telemedicine within an EMCC and utilising real-time visualization in reducing inappropriate triage of children requiring care for acute dyspnoea.
Detailed description
This is a superiority, prospective, individually randomized, open-label and monocentric study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard medical dispatching process (Control group) | No intervention | –The emergency physician dispatcher conducts a standard medical dispatching process. |
| Addition of telemedicine to standard medical dispatching process (Experimental Group) | Experimental | Other: Addition of telemedicine to standard medical dispatching process (Experimental Group)The emergency physician dispatcher conducts a standard medical dispatching process with the addition of telemedicine using video calls. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged between 3 months to 5 years
- Call from parent(s) to an EMCC for dyspnea or shortness of breath or difficulty breathing as main complaint
- Parent or witness with a phone/tablet equipped with a camera
- Emergency consent or oral consent given by the holder(s) of parental authority to the physician dispatcher
Key exclusion criteria (6 listed)
- Child in life-saving emergency
- Known absence of a telephone network required for the use of video calls
- Call made by an individual who does not hold parental authority
- Communication difficulties with the holder(s) of parental authority, not allowing for a clear and fair information
- Person not benefiting from a social security scheme or through a third party
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 |
|---|---|---|
| Addition of telemedicine to standard medical dispatching process (Experimental Group)In the experimental group, the same approach is used, with the addition of telemedicine using video calls. Callers are invited to use their smartphone camera to enable real-time video assessment. The medical dispatcher sends a secure link (via a platform provided by Enovacom, Nomadeec, Bordeaux, France) to the caller's smartphone, allowing video streaming through a secure internet connection. Once the link is validated by the caller, the live video feed from the smartphone camera is transmitted directly to the dispatcher's computer screen, providing a visual evaluation to support clinical decision-making. | Other | Addition of telemedicine to standard medical dispatching process (Experimental Group) |
Primary outcome
Proportion of patients inaccurately managed
Time frame: 24 hours
The primary endpoint is the proportion of patients inaccurately managed (over-triage or under-triage) Over-triage is defined as a situation where a patient is: 1. Directed to an ED following the call, but does not require any specific treatment, diagnostic tests, or hospitalisation, within 24h following the primary call, or 2. Managed by the deployment of a MICU, despite not requiring specific treatment or transfer to an ED, within 24h following the primary call. Under-triage is defined as a situation where a patient is kept at home with medical advice or directed to a family practitioner after the primary call AND later dispatched to hospital by a family practitioner or after a second call to an EMCC for dyspnoea, or hospitalised or dead within 24h following the primary call.
7 secondary outcomes
Proportion of patients in over-triage situation
Time frame: 24 hours
Proportion of patients in under-triage situation
Time frame: 24 hours
Proportion of patients who called a second time the emergency communication center for dyspnea
Time frame: 24 hours
Proportion of deceased patients at day 28
Time frame: 28 days
Proportion of patients hospitalized within 28 days
Time frame: 28 days
Medical decision at the end of the call
Time frame: At the end of the call to emergency communication center
Duration of the call
Time frame: At the end of the call
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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Out-of-hospital Setting
RecruitingObservational study
Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury
Brain Injuries, Traumatic, Brain Injuries, Acute
RecruitingObservational study
Resuscitative TEE Collaborative Registry
Cardiac Arrest, Cardiac Arrest Circulatory
Recruiting
Learning Cardiopulmonary Resuscitation in the School Setting: RCP-KNOW Project.
Healthy Participants, Knowledge Acquisition
Recruiting
Optimisation Strategy for Emergency Tracheal Intubation
Emergencies, Out-of-hospital Setting
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.
Nicolas Marjanovic, MD PhD principal investigator
Poitiers University Hospital
Erwan Ripley, MD principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of telemedicine to standard medical dispatching process (Experimental Group) in people with Out-of-hospital Setting and Dyspnea, 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 4 inclusion and 6 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 1 Sep 2026. 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 inaccurately managed (time frame: 24 hours). 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 1 Sep 2026.