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Recruiting NCT06847997

Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre

No phase Interventional Out-of-hospital Setting Dyspnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Addition of telemedicine to standard medical dispatching process (Experimental Group).
Who it may be relevant to
Registry conditions: Out-of-hospital Setting, Dyspnea. Basic parameters: 3 months — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre: the VISIODYS-PED Randomised Controlled Study Protocol

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Proportion of patients inaccurately managed [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU Poitiers — Poitiers

Identifiers

NCT: NCT06847997 · VISIODYS-PED

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗