NCT06847997

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Mar 2025Apr 2027

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

February 21, 2025

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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: 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.

    24 hours

Study Arms (2)

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.

Other: Addition of telemedicine to standard medical dispatching process (Experimental Group)

Interventions

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.

Addition of telemedicine to standard medical dispatching process (Experimental Group)

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, France, 86021, France

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Marjanovic, MD PhD

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR
  • Erwan Ripley, MD

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Marjanovic, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

March 30, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

June 6, 2025

Record last verified: 2025-03

Locations