NCT06335940

Brief Summary

Pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. It is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients. Proper referral of patients calling the SAMU Centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. Indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. Obtaining objective criteria such as saturation and respiratory rate is also a real challenge. To overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone). This device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea. To the best of the investigator knowledge, there is no prospective study looking at the impact of Video-Regulation on the outcome of patients requiring the advice of SAMU Centre-15 for pediatric dyspnea.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
588

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

March 14, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 14, 2024

Last Update Submit

March 30, 2024

Conditions

Keywords

VideoregulationDispatch

Outcome Measures

Primary Outcomes (1)

  • To determine in children under 10 years of age for whom a call to the SAMU38 for dyspnea is made, whether the use of Visio-Regulation reduces the percentage of emergency room admissions compared with standard telephone medical regulation.

    Percentage of participants with computerized admission to pediatric emergency departments

    24 hours

Secondary Outcomes (5)

  • Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department.

    through call completion, an average of 5 minutes

  • Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor

    through call completion, an average of 5 minutes

  • Evaluate parents' satisfaction with videoregulation compared with a standard call

    15 days

  • Evaluate the number of rescue vectors (fire brigade, private ambulance) triggered but whose decision will ultimately be to "leave on the spot" after the rescue worker's assessment.

    through out-of-hospital care completion, an average of 1 hour

  • Evaluate whether the increased use of video-regulation is not associated with a higher rate of hospitalization in a conventional ward or intensive care unit

    24 hours

Study Arms (2)

No videoregulation

An initial period of 40 days during which we leave the use of video-regulation to the discretion of the regulating physicians (emergency physicians or general practitioners) when they are faced with a call labelled by a medical regulation assistant (ARM) "Pediatric dyspnea in a child under 10 years of age" or when they themselves judge that the call falls into this category; as is the case in the current practice of the SAMU38.

Videoregulation

A 40-day period during which we will encourage regulating physicians to use video-regulation for every call concerning "pediatric dyspnea in a child aged \< 10 years".

Other: Videoregulation

Interventions

To encourage the use of video-regulation, several measures will be taken to reinforce its use as much as possible: * Posters visible to all in the dispatch room. * Regular mailings to all dispatching physicians. * On-site presence of interns and the study investigator to help doctors who are not used to video-regulation to get to grips with the computer tool. * Involvement of ARMs to remind doctors to use video-regulation.

Videoregulation

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients included in this study will be children strictly under 10 years of age whose parents have called the SAMU38 for respiratory difficulties. Therefore, patients who received ambulatory medical advice (with or without instructions to consult a general practitioner within a defined period of time), who were referred to the emergency service by their own means or who benefited from a first-aid vector (fire department or private ambulance) will be included.

You may qualify if:

  • Age strictly less than 10 years
  • Applicant calling the SAMU38 for a child with dyspnea announced or presumed by the interrogation.
  • Patients for whom no opposition from parents has been obtained.
  • Patients affiliated to social security

You may not qualify if:

  • Call to organize a secondary intervention (or Inter-Hospital Transfer (TIH/TIIH)).
  • Unsuccessful call (hung up when the dispatcher took the call, without the possibility of medical regulation).
  • Refusal to take charge on arrival of rescue vector
  • Call-back for a patient with an initial call to SAMU38 \< 48h
  • Means engaged by the CTA or an ARM even before medical regulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 28, 2024

Study Start

April 8, 2024

Primary Completion

July 31, 2024

Study Completion

October 18, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03