跳至主要内容
临床试验/NCT03701620
NCT03701620已完成不适用

Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
% of the time with reliable HRVmonitoring in children with TBI

研究概览

简要总结

Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.

详细描述

This is a single center prospective cohort study of 15 children <18 years, admitted to the PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (<24 hours). Neurodevelopment outcome of children will be evaluated 6 months post TBI.

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
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • <18 years
  • admitted to the PICU at the CHUSJ
  • moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room
  • written parental consent.

排除标准

  • children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes)
  • children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable)
  • inflicted trauma (different underlying pathophysiology)
  • patients or parents who do not speak or read English or French.

结局指标

主要结局

% of the time with reliable HRVmonitoring in children with TBI

时间窗: 1 year

Feasibility of having a reliable capture and analysis of HRV 7 days post TBI

次要结局

  • Rate of adverse events preceded by a decreased HRV(1 year)
  • HRV and neurological outcome(1.5 year)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurence Ducharme-Crevier

Pediatric intensivist, Principal Investigator

St. Justine's Hospital

研究点 (1)

Loading locations...

相似试验