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临床试验/NCT04675918
NCT04675918招募中不适用

Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): a Prospective International Multicenter Register of Cardiac Arrest in Children.

Jimena del Castillo1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Survival

研究概览

简要总结

: An intrahospital CA data recording protocol has been designed following the Utstein model. Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish. Invitation to participate has been sent to Spanish, European and Latinamerican hospitals. Variables included, asses hospital characteristics, the resuscitation team, patient's demographics and background, CPR, post-resuscitation care, mortality, survival and long-term evolution. Survival at hospital discharge will be evaluated as a primary outcome and survival with good neurological status as a secondary outcome, analyzing the different factors involved in them

详细描述

Study design: this study is a multicenter, international, prospective observational registry.

Setting: patients will be enrolled by participating investigators from European and Latinamerican countries. All sites are susceptible of treating pediatric cardiac arrest patients. Participating hospitals differ in levels of care but are all able to submit their data to the study's database.

Patient elegibility: Inclusion criteria: all children aged 1 month to 18 years who suffer a CA in hospital. For the study, CA is defined as the absence of vital signs requiring at least one minute of chest compressions. Subsequent episodes of CA may be included for the same individual.

Exclusion criteria: Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA. Patients who suffer a cardiac arrest and require ECMO for ROSC, after performing conventional CPR, will not be excluded. Duration of the data collection period 24 months.

Recruitment: Study candidates will be identified by a study physician, who will explain the study to parents or guardians. Written informed consent will be obtained from parents or guardians prior to inclusion in the study. A CONSORT (Consolidated Standard of Reporting Trials) flow diagram is shown in Figure 1.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • all children aged 1 month to 18 years who suffer a CA in hospital

排除标准

  • Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA.
  • Duration of resuscitation < 1minute

结局指标

主要结局

Survival

时间窗: Through study completition an average of 3 years

Survival

次要结局

  • Neurological outcome(5 years)

研究者

发起方
Jimena del Castillo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jimena del Castillo

MD, PhD

Hospital General Universitario Gregorio Marañon

研究点 (1)

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