跳至主要内容
临床试验/NCT03547076
NCT03547076已完成不适用

The Use of Handheld Ultrasound Utilizing Support by Experts or Automatic Analyses for Improved Diagnostics at Remote Locations

Helse Nord-Trøndelag HF2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2018年6月6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
170
试验地点
2
主要终点
Clinical influence of diagnostic ultrasound examinations supported by telemedicine

研究概览

简要总结

Heart failure causes a large patient and financial burden on the health care system. Pocket ultrasound imaging devices are utilized to improve time to correct diagnosis. Telemedicine is used in a variety of medical professions today. A combination of focused handheld ultrasound imaging performed by general practitioners and dedicated nurses in a heart failure population, utilizing telemedicine for support, has not yet been studied. The aim of the study is to evaluate the feasibility, reliability and clinical influence of implementing handheld focused cardiac ultrasound by general practitioners and nurses for diagnostics and health-related expenditure in outpatients referred with suspected heart failure.

详细描述

Handheld focused cardiac ultrasound in diagnosis of suspected heart failure

Diagnostic ultrasound is more frequently used by clinicians in different scenarios. Echocardiography (cardiac ultrasound) is the most frequently method used when diagnosing heart failure (HF), cardiomyopathies, valvular pathology and cardiac tamponade, as well as other diseases affecting the heart, great vessels and pleural cavity. Ideally, the diagnostic workflow should conclude with a correct diagnosis as soon as possible, as this is important for preserving health and quality of life for the patients, as well as for total health care expenditure and the diagnostic workflow logistics.

For the last 6-7 years smaller and cheaper ultrasound scanners have become available. These pocket-sized (or handheld) imaging devices (PSIDs) have allowed for more inexperienced users, at locations outside the dedicated ultrasound laboratories, to perform ultrasound diagnostics. PSIDs fits in the "white coat" pocket and may be brought to the patient, and thus, allowing diagnostic imaging examinations to be performed at the patients' point-of-care. PSIDs from different vendors are available on the market. Large efforts are made in developing dedicated software helping the inexperienced users to maximize the diagnostic gain of including PSIDs in the diagnostic workflow. Experts have launched the PSIDs as the next generation stethoscope.

The cardiac research groups at Levanger Hospital and NTNU (Norway) have recently evaluated the PSID Vscan® from GE Ultrasound in several studies where the PSID has been tested on cardiac patients by different users. The PSID allow for improved diagnostics by both experts, residents, general practitioners (GPs), as well as medical students and dedicated nurses.

In the inpatients setting the population is selected and the prevalence of disease is high. Research has shown that by using the PSIDs the diagnosis was corrected in up to 1 of 5 medical inpatients. With less experienced users the diagnostic impact may be reduced. Studies from outpatient hospital settings have shown that the PSIDs may allow for diagnostic gain both in cardiac and non-cardiac care. Studies evaluating the influence of using PSIDs by GPs or other health care personnel outside the hospitals are scarce. Thus, there is a need for studies evaluating the use of PSIDs or other imaging modalities performed by the GPs in the outpatient setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

盲法说明

All study personnel will be masked for findings by other study personnel. Patients will first be examined by nurses or GP in a random order, then subsequently, reference examination will be performed by cardiologist experienced in heart failure diagnostics and echocardiography.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to the outpatient clinic at Levanger Hospital for echocardiography due to suspicion of heart failure, which have consented to participate in the study.
  • N-terminal pro brain natriuretic peptide (NT-proBNP) ≥125 ng/L or brain natriuretic peptide ≥35 ng/L

排除标准

  • The patient is not able to consent.
  • The patient has know heart failure
  • Known result of any of the following cardiac imaging tests (echocardiography, cardiac magnet resonance imaging (MRI), cardiac (not coronary) computed tomography (CT).

结局指标

主要结局

Clinical influence of diagnostic ultrasound examinations supported by telemedicine

时间窗: Clinical influence will be tested on day 0 (time of study inclusion)

Clinical influence will be evaluated by the proportion of patients correct evaluated to have or not to have heart failure by the use of handheld ultrasound

次要结局

  • Feasibility of handheld cardiac ultrasound performed by general practitioners(Feasibility will be tested on day 0 (time of study inclusion))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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