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临床试验/NCT04275856
NCT04275856Unknown不适用

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

Emergency Medical Services, Capital Region, Denmark1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
State at hospital admission

研究概览

简要总结

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.

详细描述

Background In 2016 the Danish Emergency Medical Services (EMS) introduced a nationwide electronic medical reporting system. This provided new possibilities for exploring many of the aspects surrounding the daily practice the EMS, including information on selective subgroups of cardiac arrest patients. The Danish out-of-hospital cardiac arrests (OHCA) registry is based on electronic EMS reports together with a strenuous manual validation process. The product is a solid base for identification and verification of OHCA. Whenever a cardiac arrest is identified, EMS medical reports can be accessed supplying information on the background, observations and treatments that can be extracted systematically. The gain of insight from this process, provide us with the possibility to explore several novel aspects of pediatric OHCA.

OHCA is a rare event in pediatric populations with varying reports of incidence rates, ranging from 3.3 to 19.7 per 100.000 person years. Most studies, however, are centered around an incidence rate of about 8-9/100.000 person years. Generally, increased incidence rates are reported for infants compared to older children, and discrepancies in the overall incidence rates could partly be explained by different age-caps when defining the pediatric population. These inconsistencies unfortunately underline a general trend in pediatric OHCA studies, with different term definitions and data validation obscuring the overall overview and complicating more in-depth aggregate analyses. This calls for more high-quality data sources, including data validation, and a more strict adherence to standardized reporting templates such as the Utstein style for pediatric advanced life support (PALS).

Unquestionably, pediatric settings of cardiac arrest embarks an inherent urge to perform beyond ones supreme, but though discrepancies exist, overall survival is reported to be less than 11%, with 30-day survival ranging from 8.1% to 11%, and survival until hospital discharge ranging from 2% to 10.9%. This leads to a potential for improvement, which requires first and foremost clarification of the most obvious causes.

The etiology of OHCA is often categorized by cardiac or non-cardiac etiology as an object of prevention and post-mortem determination. However, OHCA in children are less likely to be a primary cardiac event. When the focus is solely on increasing survival, reversible causes is more often the focus and is labelled a key component of adult advanced resuscitation algorithms. The most commonly used denomination for reversible causes to consider during advanced life support is "H's" (Hypoxia, Hypovolemia, Hydrogen ion (acidosis), Hypo-/hyperkalemia and Hypothermia) and "T's"(Toxins, Tamponade cardiac, Tension pneumothorax, Thrombosis, pulmonary and Thrombosis coronary). Likewise, PALS operate in "H's" and "T's", and more often than not, prescribe a primary focus on hypoxia as the most prominent reversible cause.

The investigators speculate that the EMS medical reports provide new and central information about etiology and, perhaps more central to survival, reversible causes of pediatric OHCA.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

State at hospital admission

时间窗: Through study completion, an average of 1 year

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

Etiology of cardiac arrest

时间窗: Through study completion, an average of 1 year

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.

Return-of-spontaneous-circulation (ROSC)

时间窗: Through study completion, an average of 1 year

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).

30-day Survival

时间窗: Through study completion, an average of 1 year

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.

Incidence rate

时间窗: Through study completion, an average of 1 year

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

次要结局

未报告次要终点

研究者

发起方
Emergency Medical Services, Capital Region, Denmark
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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