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Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST)

2021年8月3日 更新者:Singapore General Hospital

Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST): a Pilot Study

Work-related musculoskeletal disorders (WRMSD) among sonographers/radiographers are prevalent in the healthcare industry. This pilot study will evaluate the use of a robotic assisted ultrasonography system (ROBUST) against the conventional abdominal ultrasound scanning procedure. The ROBUST will be developed to provide 6 degrees of freedom to allow radiographers to perform abdominal scanning without having to reach over patients.

10 sonographers with at least 5 years of experience will be recruited from SGH and SKH, to perform abdominal ultrasound scans on healthy volunteers. Each sonographer will be randomly assigned to scan a volunteer using conventional abdominal ultrasound scanning procedure and with ROBUST respectively. The study will be done in 2 phases, separated by at least a 1-month interval between scans.

Phase 1: Scanning of volunteer using conventional abdominal ultrasound scanning procedure.

Phase 2: Scanning of volunteer using ROBUST. Outcome measures will include ultrasound image quality, sonographer feedback and comfort level as well as satisfaction feedback from healthy volunteers. A panel of 4 reviewers, consisting of 2 radiologists and 2 senior radiographers will be invited to grade the images, using a 3-point Likert scale. The duration of each scanning will be recorded. The comfort level reported by sonographers will be assessed using the SGH Comfort Level Survey. In addition, the comfort level of healthy volunteers will also be assessed using a satisfaction questionnaire.

研究概览

地位

完全的

详细说明

  • 10 participating sonographers will be recruited from SGH and SKH to perform abdominal ultrasound scanning.
  • 10 healthy volunteers of average body habitus with BMI <30, abdominal circumference <102cm will be recruited.
  • Each sonographer will be randomly assigned to scan 1 healthy volunteer. The same volunteer will be scanned twice with an interval of at least 1 month between two scans: once using conventional abdominal ultrasound scanning procedure and once using ROBUST.
  • During the session, markers coated with a retroreflective material to reflect light to the motion capture camera will be pasted on participating sonographers on various parts of the upper limb.
  • Surface electromyography (sEMG) electrodes will be affixed on sonographers' upper trapezius, deltoid, biceps, triceps, wrist extensors and flexors to monitor muscle activities.
  • The healthy volunteer will lie on a plinth with the participating sonographer seated next to him/her. The sonographer will then perform scanning on various abdominal organs following the point of reference and scanning approach as indicated.
  • The same ultrasound scanner and probe type will be used on all volunteers by all sonographers.
  • Static bilateral grip strength of participating sonographers will be measured using a dynamometer before and after each scan.
  • At the end of both scans, participating sonographers will be required to complete a survey on comfort level.
  • At the end of both scans, healthy volunteers will be required to complete a survey on satisfaction level.
  • The quality of the images from both scans will be rated by 4 readers: 2 consultant radiologists and 2 senior radiographers. A photometer will be used to ensure all readers interpret images directly from a designated monitor under consistent lighting condition.

研究类型

观察性的

注册 (实际的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、169608
        • Singapore General Hospital
      • Singapore、新加坡、544886
        • Sengkang General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

10 sonographers from SGH or SKH and 10 healthy volunteers.

描述

Inclusion Criteria:

Sonographer:

-Experienced sonographers/ radiographers with more than 5 years of experience

Healthy volunteer:

  • Inclusion criteria: - BMI <30
  • Abdominal circumference <102cm

Exclusion Criteria:

Sonographer:

-Participating sonographers with previously reported work-related or non-work related musculoskeletal discomfort or injury

Healthy volunteer:

-Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Comparison of quality of ultrasound image for manual scanning and robot scanning
大体时间:During the scan
During the scan
Kinematic data, Range of Motion from motion capture system
大体时间:During the scan
During the scan
Muscle activation from EMG data
大体时间:During the scan
During the scan
Static bilateral grip strength
大体时间:Immediately before the scan and immediately after the scan
Immediately before the scan and immediately after the scan
Questionnaire on comfort level from sonographers
大体时间:immediately after the scan
immediately after the scan
Questionnaire on Satisfaction level from healthy volunteers
大体时间:immediately after the scan
immediately after the scan

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年6月1日

初级完成 (实际的)

2019年5月31日

研究完成 (实际的)

2019年5月31日

研究注册日期

首次提交

2021年7月25日

首先提交符合 QC 标准的

2021年8月3日

首次发布 (实际的)

2021年8月12日

研究记录更新

最后更新发布 (实际的)

2021年8月12日

上次提交的符合 QC 标准的更新

2021年8月3日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2017/3049

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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