Clinical trial NCT06847997: Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre
Official title: Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre: the VISIODYS-PED Randomised Controlled Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-of-hospital Setting
Dyspnea
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 339
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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.


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

Primary outcomes:
measure: Proportion of patients inaccurately managed
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Nicolas Marjanovic, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poitiers University Hospital
name: Erwan Ripley, MD
role: PRINCIPAL_INVESTIGATOR
References: