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临床试验/NCT03327688
NCT03327688已完成不适用

Point-of-care Ultrasound in Finland

Ossi Hannula7 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2017年10月20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
220
试验地点
7
主要终点
Length of stay in emergency department

研究概览

简要总结

This study has two aims.

  1. Deep venous thrombosis (DVT) is a common suspected medical condition. If it cannot be excluded clinically and using D-dimer, ultrasound examination is required. An option for traditional radiologist-performed ultrasound is a 2-point compression ultrasound (2-CUS). The safety of this technique is proven. However there does not exist any data on costs comparing traditional and 2-CUS pathways in primary health care. This study will evaluate the total cost of both pathways by conducting a cost-minimization analysis. It will also study the effect of a simple ultrasound education on the referrals to hospital due to suspected DVT.

Hypothesis 1: Short education in ultrasound will reduce significantly referrals to hospital and save resources. 2. Length of stay (LOS) in emergency department (ED) is related to increased mortality, morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be compared to those that have a radiology performed ultrasound examination. Further examination and accuracy of POCUS will be noted.

Hypothesis 2: POCUS can shorten LOS significantly in selected clinical conditions

详细描述

This study has two aims.

  1. Deep venous thrombosis is a common suspected medical condition. If it cannot be excluded clinically and using D-dimer, ultrasound examination is required. An option for traditional radiologist-performed ultrasound is a 2-point compression ultrasound (2-CUS). The safety of this technique is proven. However there does not exist any data on costs comparing traditional and 2-CUS pathways in primary health care. This study will evaluate the total cost of both pathways by conducting a cost-minimization analysis. It will also study the effect of a simple ultrasound education on the referrals to hospital due to suspected DVT. T

he study is performed in Saarikka Primary Care Public Utility, Saarijärvi, Finland. There are 15 general practitioners (GP) working. During year 2014, 2 of them were performing 2-CUS. 9 of the other GPs were trained during years 2015-2016 to perform a 2-CUS and hence 11 of 15 GPs are able to do 2-CUS in 2017.

This is a register study. Referrals to hospital in 2014 (pre-training) and 2017 (post-training) are examined and the difference is assumed to be because of training and new pathway. Based on population the expected number of referrals due to a suspected DVT should be approximately 100 annually and the expected number after intervention is 30. According to power analysis a reduction from 100 to 76 is statistically significant (p<0.05).

Hypothesis 1: Short education in ultrasound will reduce significantly referrals to hospital and save resources. 2. Length of stay (LOS) in emergency department (ED) is related to increased mortality, morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be compared to those that have a radiology performed ultrasound examination.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Emergency department patient
  • A suspected medical condition, that can be confirmed or excluded by basic POCUS exam, including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb, pneumothorax, early pregnancy with non-specified location (confirming intrauterine pregnancy), hydronephrosis.
  • Emergency medicine specialist or resident decides to perform a POCUS exam

排除标准

  • age under 18
  • not able to give informed consent in Finnish

结局指标

主要结局

Length of stay in emergency department

时间窗: Duration of a single emergency department visit. Up to 48 hours.

time between registration in emergency department and "finished from doctor" sign.

次要结局

  • Accuracy of POCUS exam findings(6 months)
  • Need for follow-up radiologist performed imaging(6 months)

研究者

发起方
Ossi Hannula
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ossi Hannula

MD, emergency medicine resident

Kuopio University Hospital

研究点 (7)

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