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临床试验/NCT03728491
NCT03728491Unknown不适用

Training Thoracic Ultrasound Skills: a Multicentre, Blinded, Randomized Controlled Trial of Simulation-based Training Versus Training on Healthy Figurants

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Difference in LUS-OSAUS score

研究概览

简要总结

The use of thoracic ultrasound has expanded widely within the las couple of years, and several studies have proved a high diagnostic accuracy for many of the most common causes of respiratory failure and dyspnoea.

The ultrasound scan is a bed-side, and dynamic examination, which demands sufficient theoretical and practical knowledge and competence by the operator, but so far, no studies have explored the effect of simulation-based training for gaining adequate competence compared to traditional hands-on training on healthy figurants.

The aim of this study is to examine whether TUS training on a simulator is superior to training on healthy figurants. Secondly, to examine whether the choice of hands-on training has an effect on the number of examinations performed by the trainees from baseline to 4 months follow-up.

详细描述

Thoracic ultrasound (TUS) differs from ultrasound examinations in other organ systems, because it is not possible in the healthy, ventilated lung to visualize structures or anatomical parts of the lung, like it is when examining abdomen or performing an echocardiography. It is therefore not possible to transfer results directly from educational studies using simulation-based training in other areas of medicine, to thoracic ultrasound.

TUS examinations are considered safe, and without pain, exposure to radiation or delay of patients' course, but ultrasound in general is highly operator dependent and lack of theoretical knowledge or practical skills could potentially lead to incorrect diagnosis and thus treatment. Therefore simulation-based training, theoretical and practical tests could be the key to a "pre-trained novice" with a level of competency higher than a complete novice when performing the first TUS examination on a patient in a clinical setting.

The objective of this trial is to examine whether TUS training on a simulator is superior to training on healthy figurants, which today is a commonly used method for gaining skills and competencies in TUS. Secondly, to examine whether the choice of hands-on training has an effect on the number of examinations performed by the trainees from baseline to 3 months follow-up.

Methods The design is a three-armed, multicentre, blinded randomized controlled trial. The trial takes place at three simulation centres at university hospitals in Denmark; Odense University Hospital, Rigshospitalet, and Aarhus University Hospital. The intervention period is scheduled to run from August 2018 to May 2019.

Participants All physicians employed at public hospitals in Region of Southern Denmark, Capital Region of Denmark, Region Zealand, and Central Denmark Region, are eligible for inclusion in the trial. Because physicians from a wide range of specialities can benefit from TUS examinations, no exclusion criteria are established based on the specialities from the physicians.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Physicians with no previous experience in thoracic ultrasound

排除标准

  • Physicians with relation to the trial or study
  • Physicians with previous experience in thoracic ultrasound
  • Physicians who do not provide written consent

研究组 & 干预措施

Healthy Figurant

Experimental

Hands-on training on healthy figurants for gaining competence in TUS

干预措施: Healthy figurants (Device)

Simulator

Experimental

Hands-on training on US Mentor simulator for gaining competence in TUS

干预措施: Simulator (Device)

Controls

No Intervention

Controls with no hands-on training

结局指标

主要结局

Difference in LUS-OSAUS score

时间窗: 3 months (on the day of practical assessment, maximum 3 months after inclusion)

Difference in assessment score (Lung Ultrasound Objective Structured Assessment of Ultrasound Skills score) between the three groups (total score). The scale comprises 17 items with a score from 1-5 in each. Minimum 17, maximum 85, meaning that a score of 85 point is the best possible ultrasound examination.

次要结局

  • Time used for hands-on training(3 months (on the day of practical assessment, maximum 3 months after inclusion))
  • Number of performed examinations(4 months after day of practical assessment)

研究者

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

Pia Iben Pietersen MD

MD, phd-student

Odense University Hospital

研究点 (2)

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