NCT05474131

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

3.2 years

First QC Date

July 18, 2022

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • death from any cause within thirty days of admission

    The vital status at Day 30 will be systematically sought.

    at day 30

Secondary Outcomes (1)

  • Resuscitation in pre-hospital care during the listening of the sound tapes of the SAMU

    at day 1

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

population under 18 years old, with out-of-hospital cardiac arrest

You may qualify if:

  • child under 17 years old
  • and call for cardiac arrest or cardiac arrest detected on call

You may not qualify if:

  • non-real cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Laure ABENSUR VUILLAUME, PhD, MD

    CHR Metz Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 26, 2022

Study Start

January 1, 2019

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations