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临床试验/NCT05093439
NCT05093439已完成不适用

Heart Rate Variabitlity at the Emergency Department: a New Triage Parameter?

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 532 人开始时间: 2021年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
532
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

In this study investigators want to examine if heart rate variability at hospital entry predicts prognosis in participants with severe disease.

详细描述

Predictive parameters that can predict the outcome are very scarce. Vital parameters such as heart rate, blood pressure, saturation, etc. can be normal for a long time or only slightly changed, even in seriously ill patients. Heart rate variability is a parameter that can be used as a measure of autonomic dysfunction. Lower heart rate variability is associated with increased mortality and morbidity according to recent studies. Heart rate variability could thus be used to identify the need for intervention and treatment more quickly.

In this study, we want to investigate whether there is indeed a relationship between heart rate variability at admission to the emergency department and eventual mortality and morbidity in critically ill patients.

Therefore, heart rate variability will be determined in patients admitted to the emergency department who were triaged in red or orange according to the Manchester Triage System (internationally validated triage system that is also used in the emergency department at UZ Gent). Subanalyses will be made for patients with trauma, sepsis, pneumonia, CVA and acute myocardial infarction. Determination of heart rate variability will be done by EKG monitoring during the first 5 minutes and after 3 hours. There are several parameters that can reflect heart rate variability. Both frequency domain measurements and non-linair measurements will be determined. Use will be made of the Kubios programme, a free programme that can determine these different parameters on the basis of EKG monitoring. Patients who are resuscitated on arrival will be excluded, as well as patients in VKF, as the heart rate variability on arrival cannot be determined for these two groups. Demographic data (age, sex,...), history and home medication, vital parameters (heart rate, blood pressure, saturation, temperature, respiratory rate) and some lab data (lactate, CRP) will also be collected. The primary outcome will be mortality after 30 days. Secondary outcomes that will be studied are the total duration of hospital stay and the duration of stay in the intensive care unit, as well as the need for life-saving interventions (need for surgery, ventilation, inotropics, PCI or thrombolysis).

By collecting these data, we want to find out whether heart rate variability is a good predictor of outcome, and thus the need for ICU admission, faster invasive interventions,... During this study, the patient's management will remain unchanged.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system

排除标准

  • Patients with cardiac arrest or arrhythmia at arrival

结局指标

主要结局

30-day mortality

时间窗: 30 days

次要结局

  • Length of stay at the intensive care unit(0 - 100 days)
  • Length of Hospital Stay(0 - 100 days)
  • Need for life threatening interventions(In 0 - 7 days after admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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