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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05474131
Other study ID # 2022-07Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date March 15, 2022

Study information

Verified date July 2022
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this observational and retrospective study is to determine the predictive factors of in-hospital mortality following an out-of-hospital cardiopulmonary arrest (CPA) in the population under 18 years old. Data are collected from telephone calls and medical regulation records processed by the health call center of 2 french departments between January 1, 2019, and March 15, 2022. The medical records of the included patients will also be reread in order to obtain the patient's status at 30 days after the CPA. Detailed description: The literature reports numerous works evaluating the epidemiological characteristics of pediatric out-of-hospital cardiorespiratory arrest. An improvement in survival has been reported in the case of resuscitation guided by the operator in medical regulation before the arrival of the emergency services. Indeed, the regulation phase at the 15 center in France is of fundamental importance. Recent evolutions, notably with the creation of specific call-taking professions, show the importance attached to improving practices. The population concerned is characterized by children under 18 years of age, victims of an extra-hospital cardiorespiratory arrest. It is a retrospective study over three years and three months, multicentric, from the emergency service (SAMU) 57 and 69. The primary endpoint was the all-cause mortality at thirty days of the admission. The case report form (CRF) will collect the main aspects of telephone management at the 15 centers, out-of-hospital management by the emergency teams, and the personal characteristics of the emergency physicians and out-of-hospital responders (gender, age, family situation, etc.). The medical management in the emergency department and the first stages of in-hospital management will also be analyzed. The patients included who are still alive will receive a notification of non-objection by mail.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date March 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers
Gender All
Age group 1 Day to 17 Years
Eligibility Inclusion Criteria: - child under 17 years old - and call for cardiac arrest or cardiac arrest detected on call Exclusion Criteria: - non-real cardiac arrest

Study Design


Locations

Country Name City State
France CHR Metz-Thionville/Hopital de Mercy Metz

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary death from any cause within thirty days of admission The vital status at Day 30 will be systematically sought. at day 30
Secondary Resuscitation in pre-hospital care during the listening of the sound tapes of the SAMU The resumption of a spontaneous cardiac activity will be sought during the listening of the sound tapes of the SAMU at day 1
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