跳至主要内容
临床试验/NCT04049370
NCT04049370Unknown不适用

Examination of the Standardized Use of the Pulmonary Embolism SOP in the Clinical Routine of the Emergency Department in Respect of the QEST Criteria (Quality, Efficacy, Safety and Transparency).

Heidelberg University0 个研究点目标入组 200 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
Guideline adherence

研究概览

简要总结

Usage of a guideline-compliant SOP in each chest pain unit (CPU) is instrumental in establishing the diagnosis of a pulmonary embolism without time delay. With the integration of this SOP as a "clinical decision tool" (CDT) into the electronic database of the CPU, the standardized application of the pulmonary embolism SOP in the clinical routine of the CPU will be tested using a retro- and prospective approach.

详细描述

Summary:

The increasing number of patients in the emergency departments in recent years extends the time until diagnosis and treatment initiation and thus represents a serious problem in patient care and for the treating physician. This also includes patients with acute pulmonary embolism (PE), which is one of the most common differential diagnoses of patients presenting with unclear dyspnea, chest pain or other symptoms in the emergency department. Due to the potentially serious clinical outcome with a high overall mortality rate of > 10%, rapid diagnosis and initiation of therapy is essential.

The current guidelines of the European Society of Cardiology for the diagnosis and treatment of acute PE recommend a stringent diagnostic algorithm that includes clinical parameters as well as risk scores for estimating the pretest probability. Depending of their results the further diagnostic pathway by D-Dimer testing and / or CT angiography is chosen.

The aim of the present study is to examine the standardized application of guideline recommendations of the European Society of Cardiology (ESC). The diagnostic procedures were defined for the CPU of the University Hospital Heidelberg in a standard operating procedure (SOP). In the planned retrospective study, the implementation of this SOP will be examined on the basis of the QEST criteria (quality, efficacy, safety and transparency). Data for the "actual condition" are collected retrospectively for 6 months prior to August 2019, thereafter for another 6 months after implementation of the quality assurance measure.

Introduction and fundamental principles:

研究设计

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

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 over the age of 18 with suspected pulmonary embolism in the CPU (with or without D-dimer determination)

排除标准

  • Patients in whom the determination of the D-dimer concentration was made for other reasons, such as venous thrombosis or aortic syndrome
  • Patients who have been suspected to have a pulmonary embolism already before presenting in the CPU
  • Patients with confirmed diagnosis or already measured D-dimers

结局指标

主要结局

Guideline adherence

时间窗: 6 months

• Percent guideline adherence or violation of guideline recommendations (quality)

Appropriateness of CT imaging

时间窗: 6 months

• Ratio of diagnostic CT: total CT

Missed pulmonary embolism

时间窗: 6 months

* Number of indicated but not performed CT examinations * Number of unnecessary CT at low pretest probability

次要结局

  • Appropriate biomarker utilization(6 months)
  • efficacy of CT imaging(6 months)
  • Inappropriate biomarker utilization(6 months)

研究者

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

Evangelos Giannitsis

Principle Investigator

Heidelberg University

相似试验