Etiology, Incidence and Survival of Pediatric Out-of-hospital Cardiac Arrests: a Four-year Danish Analysis

NCT04275856 | Unknown

• 1 other identifier: Child-OHCA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background: OHCA is a rare condition for children and young adults. Overall incidence rates are reported as 3.3-5.97 per 100.000 inhabitants. Previous studies from different data sources have identified a diverse and slightly incompatible etiologies. The purpose of this investigation was to analyze presumed etiologies of pediatric OHCA and report incident and survival rates. Further the investigators wish to present central characteristics of pediatric OHCA in Denmark. Methods: Data will be collected from the verified 2016-2019 Danish OHCA register. Inclusion criteria were age ≤ 16 years at the time of the event. All included EMS reports will read by two authors \[MGH and TWJ\] and the presumed reversible cause assigned to each case. Incidence rates per 100.000 citizens, survival rates to hospital, initial rhythm, use of AED by laypersons, EMS treatment and presumed etiology are reported. To test feasibility a study was conducted in 2018, on the 56 verified cases of children with OHCA was reported in the capital region of Denmark in 2016-2018 (among 1.8 million inhabitants). Incident rates were 0.83-1.34 per 100.000 inhabitants per year. Preliminary data show survival to hospital was 46% which was markedly higher than the adult population (28%, p = 0.002). The most common cause of OHCA was hypoxia (50%) followed by trauma/hypovolemia (14%) and others (7%). Approximately 23% did not present with an apparent etiology. Hereditary disorders as the primary cause was noted in 7% of the cases. The conclusion from the feasibility study is that the study is possible and that a reasonable proportion of pediatric OHCA can be analyzed from EMS medical reports. Expected outcome: Variables included in the study: age, gender, initial rhythm, etiology of cardiac arrest, event location, observation of occurrence, cardio-pulmonary-resuscitation (CPR), defibrillation and use automatic external defibrillators (AEDs), EMS-response time, hospitalization, return-of-spontaneous-circulation (ROSC), state at hospital admission, 30-day survival, airway management and use of epinephrine. See the dedicated study protocol for an extended description of the variables and associated analyses.

Conditions

Out-Of-Hospital Cardiac Arrest; Pediatric Disorder; Cardiopulmonary Arrest

Outcome Measures

Primary Outcomes (5)

• Return-of-spontaneous-circulation (ROSC)

  ROSC will be defined as cases achieving ROSC anytime between recognition of the event and termination (defined as either hospital admission og declaration of death by EMS-personnel).

  Through study completion, an average of 1 year

• State at hospital admission

  The investigators will define the case state on arrival at the hospital as either; ROSC or ongoing CPR.

  Through study completion, an average of 1 year

• 30-day Survival

  Survival will be defined as ROSC at the time of hospital admission. Further the investigators will include rates for 30-day survival derived with data from the National Patient Registry.

  Through study completion, an average of 1 year

• Etiology of cardiac arrest

  Presumed etiology will be categorized as either reversible (including a subcategorization into the 4H's and 4T's) and non-reversible. Further, the investigators aim to categorise the preceding event, stratifying this into either; a medical cause, trauma, drug overdose, drowning, asphyxia, sports-related or suicide.

  Through study completion, an average of 1 year

• Incidence rate

  Incidence rate of paediatric out-of-hospital cardiac arrest per 100.000 citizens and equivalent measures for age specific subgroups

  Through study completion, an average of 1 year

Other Outcomes (4)

• Airway management

  Through study completion, an average of 1 year

• Use of epinephrine

  Through study completion, an average of 1 year

• Defibrillation and use automatic external defibrillators (AEDs)

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The external verification team indirectly mark cases as pediatric, whenever a subject is less than 16 years of age at the time of the event. This together with age derived from individual personal identification numbers is used to identify all pediatric cases. All Danish citizens is provided with a unique personal identification number at birth, containing the individuals date-of-birth.

You may qualify if:

• All out-of-hospital cardiac arrests victim from 0-16 year of age.
• The external verification team indirectly mark cases as pediatric, whenever a subject is less than 16 years of age at the time of the event. This together with age derived from individual personal identification numbers is used to identify all pediatric cases. All Danish citizens is provided with a unique personal identification number at birth, containing the individuals date-of-birth.

You may not qualify if:

• Subjects reported as unquestionably deceased (late signs of death) at EMS arrival will be excluded.

Sponsors & Collaborators

• Emergency Medical Services, Capital Region, Denmark: lead
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator
• TrygFonden, Denmark: collaborator

Study Sites (1)

Copenhagen Emergency Medical Services

Copenhagen, 2750, Denmark

Location

Related Publications (23)

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MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Freddy K Lippert, MD, Ass. Professor

  Copenhagen Emergency Medical Services

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: February 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

DK (1)