Videokonferanser for styring av pediatrisk dyspné i et akuttmedisinsk telefonsenter (VISIODYS-PED)
Videokonferanser for styring av pediatrisk dyspné i et akuttmedisinsk telefonsenter: Visiodys-ped randomisert kontrollert studieprotokoll
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a superiority, prospective, individually randomized, open-label and monocentric study.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
France
-
Poitiers, France, Frankrike, 86021
- CHU Poitiers
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Standard medical dispatching process (Control group)
The emergency physician dispatcher conducts a standard medical dispatching process. |
|
|
Eksperimentell: 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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients inaccurately managed
Tidsramme: 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:
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. |
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients who called a second time the emergency communication center for dyspnea
Tidsramme: 24 hours
|
24 hours
|
|
|
Proportion of deceased patients at day 28
Tidsramme: 28 days
|
28 days
|
|
|
Proportion of patients hospitalized within 28 days
Tidsramme: 28 days
|
28 days
|
|
|
Proportion of patients in over-triage situation
Tidsramme: 24 hours
|
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. |
24 hours
|
|
Proportion of patients in under-triage situation
Tidsramme: 24 hours
|
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. |
24 hours
|
|
Medical decision at the end of the call
Tidsramme: At the end of the call to emergency communication center
|
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. |
At the end of the call to emergency communication center
|
|
Duration of the call
Tidsramme: At the end 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) |
At the end of the call
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Nicolas Marjanovic, MD PhD, Poitiers University Hospital
- Hovedetterforsker: Erwan Ripley, MD, Poitiers University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VISIODYS-PED
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Desidentified participant data will be available from the corresponding author upon reasonable request, after approval of a proposal and signature of a data access agreement
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .