Admission for Respiratory Disease And VIdeo Regulation System

Pediatric Respiratory Diseases Clinical Trial

— ARAVIS-PED  

Official title:

Admission for Respiratory Disease And VIdeo Regulation System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335940
• Other study ID #: 38RC23.0376
• Status: Not yet recruiting
• Start date: April 8, 2024
• Est. completion date: October 18, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Grenoble
• Contact: Guillaume Debaty
• Phone: 0476634256
• Email: gdebaty[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 588
• Est. completion date: October 18, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pediatric Respiratory Diseases
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Videoregulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department.	Percentage of participants among all calls referred to outpatient and inpatient medicine	through call completion, an average of 5 minutes
Secondary	Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor	Call time spent with the regulating physician	through call completion, an average of 5 minutes
Secondary	Evaluate parents' satisfaction with videoregulation compared with a standard call	Rating of appellants' satisfaction with the decision on a numerical scale from 1 to 5. 1 being the lowest level of satisfaction and 5 being the highest.	15 days
Secondary	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.	Number of people left behind after a rescue vehicle has been deployed.	through out-of-hospital care completion, an average of 1 hour
Secondary	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	Number of patients admitted to hospital or intensive care/resuscitation after emergency admission within 24 hours of the call	24 hours