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临床试验/NCT05773547
NCT05773547招募中不适用

Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using the Multispectral Optoacoustic Tomography

University Hospital Erlangen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Learning curve in MSOT measurements.

研究概览

简要总结

The goal of this observational study is to investigate the learning effect in the measurement of micro-circulation in healthy participants using MSOT. The main question it aims to answer are:

If there if a learning effect in MSOT measurement. How long does it takes for the trainees to reach the professional level. Is there a difference between different learning methods? Participants will have to lie on the examination bed while investigator making measurements 7 times in a row on one single location.

详细描述

Learning effect of MSOT measurements have been observed by previous studies. Therefore, in this study, we aim to quantify the learning effect with circulation-related parameters (Hb, HbO2, SO2) and the similarity between repeated images (structural similarity index measure, SSIM). The measurement would be repeated by 5 different investigators, two of them are professionals, defined as experience over 200 times of MSOT measurement, while the other three are trainees, who haven't performed any MSOT measurements before and each has received one different teaching method, one receiving personal teaching from a professional, one receiving video instruction and one receiving instructions written in paper form.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • all those who with the age between 18 and 40 year-old

排除标准

  • diabetes mellitus
  • hypertension
  • cardiovascular diseases
  • chronic kidney diseases
  • amputation in either lower extremities
  • tatoos in either lower extremities

结局指标

主要结局

Learning curve in MSOT measurements.

时间窗: 5 days

If the quality of MSOT measurements improved with practices.

Different learning curve between professionals and trainees.

时间窗: 5 days

Observe the possible difference between the learning curves in professionals and trainees.

次要结局

  • Different learning curve in three different teaching methods(5 days)

研究者

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

Ulrich Rother

PD Dr. med.

University Hospital Erlangen

研究点 (1)

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