跳至主要内容
临床试验/NCT04003883
NCT04003883已完成不适用

ST-T Segment Changes in Emergency Physicians While on Duty

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年11月1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
25
试验地点
1
主要终点
ST-T segment change

研究概览

简要总结

Preclinical emergency management is frequently associated with a combination of physical and psychological stress.

This stress is known to lead to a broad variety of changes in the physiology even extending in the cardiovascular system. Both physical and psychological stress induces ECG changes. These changes include not only arrhythmias but also deviations in ST-T segment representing the phase of repolarization.

Information about changes in ST-T segment are missing until now. The investigators hypothesise that ST-T deviations occur in emergency physicians during shift at an emergency response car.

In order to show changes in ST-T segment a prospective observational trial will be conducted. By using a 12 lead ECG Holter the investigators will obtain ECGs during shifts of emergency physicians at an emergency response vehicle.

During 12-hour shifts emergency physicians will be attached to the 12 lead Holter ECG. ECGs will be analysed after blinding of names and reason of call (code) to the investigators. The primary outcome will be ST-T segment changes greater than 0.1mV in two corresponding leads for more than 30 seconds per 100 calls.

As secondary outcomes, other ECG changes such as ST-T segment changes <0.1mV, T wave inversion or HRV will be analysed. Furthermore, surrogate parameter of stress will be measured using NASA-Task Load Index and cognitive appraisal and correlated to ST-T segment changes. Correlations between different phases of calls, different indications of calls and ECG changes will be assessed. Furthermore, correlation between alarm codes apriori defined as stressfull using a delphi process and ST-T segment changes as well es surrogate parameters of stress will be assessed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy emergency physicians doing shifts at the Medical University of Vienna's emergency response car

排除标准

  • Known pregnancy
  • Pre-existing cardiac diseases (valvular heart disease > I°, any form of cardiomyopathy, history of coronary artery disease, history of myocarditis, any channelopathy, known high degree (>1% of all beats within 24h) premature atrial or ventricular beats or atrial fibrillation or conduction disturbance.
  • Any antiarrhythmic therapy
  • Any implanted cardiac device
  • Manifest Hyperthyroidism
  • Termination of exercise testing due to the commonly used criteria26 or not reaching 85% of maximal predicted load.

结局指标

主要结局

ST-T segment change

时间窗: Day1-3

ST-T segment changes of at least 0.1mV in two corresponding leads occurring for more than 30 seconds per 100 prehospital emergency response calls

次要结局

  • ST-T segment change <0.1mV, <30sec.(Day1-3)
  • T wave inversion > 30sec.(Day1-3)
  • T wave inversion <= 30sec.(Day1-3)
  • Changes in HRV(Day1-3)
  • Association of different phases of a call to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.(Day1-3)
  • Association of different phases of a call to changes in HRV (SDNN, r-MSSD and pNN50)(Day1-3)
  • Association of the ten most stressful alarm codes to changes in ST-T segments > 0.1mV in two corresponding leads for > 30sec.(Day1-3)
  • Association of the ten most stressful alarm codes to changes in HRV (SDNN, r-MSSD and pNN50)(Day1-3)
  • Psychological stress during calls by means of NASA TLX(Day1-3)
  • Frequency of calls being perceived as threat by using cognitive appraisal testing(Day1-3)
  • Association of stressful and non-stressful calls to psychological stress measured using NASA TLX(Day1-3)
  • Correlation of events logged(Day1-3)
  • Association of NASA TLX to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.(Day1-3)
  • Association of cognitive appraisal to ST-T segment changes > 0.1mV in two corresponding leads for > 30sec.(Day1-3)
  • Association of stressful and non-stressful calls to cognitive appraisal and calls that are perceived as threat.(Day1-3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathias Maleczek

Registrar

Medical University of Vienna

研究点 (1)

Loading locations...

相似试验