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Current Practice of Patients Undergoing C-arm Procedures at the Operating Department

2022年4月12日 更新者:Maastricht University Medical Center

Baseline Study on Current Practice of Patients Undergoing C-arm Procedures of Extremities or Spinal Cord at the Operating Department of the Maastricht University Medical Center+

All x-ray systems at the MUMC+ are currently operated by radiodiagnostic technicians. This is also the case for C-arms used during surgical procedures at the OR-complex. Because a gain in time efficiency is expected (i.e. not for research related reasons), a group of OR-personnel will be in-house trained to qualify for operating C-arms in low complex procedures. The shift towards C-arm procedures performed by OR personnel has been initiated also in other hospitals as it is expected to be time saving without loss of quality. However, this is an assumption and not proven by any scientific evidence. Several aspects are interesting for scientific studies as little is known about the effects of this shift on image quality, radiation dose, time efficiency and to guarantee that there is no loss of quality for the patient.

This study investigates the standard care, where radiodiagnostic technician operate the C-arms.

This study is set up such that it can serve as a baseline for a future study in which it will be assessed whether the quality of care when OR-personnel operates the C-arms is non-inferior to the standard care.

The aim of the study is to prospectively assess the standard care.

Research questions are twofold:

  1. What is the current practice and current time efficiency of C-arm procedures performed by radiodiagnostic technicians?
  2. What is the current quality of C-arm procedures operated by radiodiagnostic technicians?

研究概览

研究类型

观察性的

注册 (预期的)

540

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population consists of consecutive patients who undergo a low complex C-arm procedure (lower or upper extremities) or a high complex C-arm procedure (lower extremities or spinal cord) during the study period at the OR complex of the MUMC+.

描述

Inclusion Criteria:

  • All C-arm OR-procedures performed at the OR-complex of the MUMC+;
  • Type of procedure is: low complex: extremities (upper or lower), high complex: lower extremities, spinal cord (four procedure types).

Exclusion Criteria:

  • No informed consent;
  • Incomplete procedure information and technical parameters;
  • Withdrawal of informed consent by the study patient.

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
措施说明
大体时间
Gross and nett OR time [minutes]
大体时间:1 day
Measures for time efficiency, recorded by assistent investigator during procedure
1 day
Radiation dose (DAP[Gycm2])
大体时间:1 day
Measure for quality
1 day

次要结果测量

结果测量
措施说明
大体时间
Time spent by and type of personnel involved [minutes, predefined role]
大体时间:1 day
Measure for efficiency, recorded by assistent investigator during procedure
1 day
Amount of time spent inefficiently [minutes]
大体时间:1 day
Measure for efficiency, recorded by assistent investigator during procedure
1 day
Occupancy time C-arm [minutes]
大体时间:1 day
Measure for efficiency, recorded by assistent investigator during procedure
1 day
Downtime (technical failures) [minutes]
大体时间:1 day
Measure for efficiency, recorded by assistent investigator during research period
1 day
Number of revision surgeries
大体时间:1 month
Measure for quality, recorded by assistent investigator 1 month after the procedure
1 month
Radiation dose (Dose in ref_point [mGy])
大体时间:1 day
Measure for quality, obtained from C-arm
1 day
Image quality subjective scoring
大体时间:1 day
Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality)
1 day
Number and type of help requests
大体时间:1 day
Measure of quality and efficiency, recorded by assistent investigator during procedure
1 day
Collimation [cm2]
大体时间:1 day
Measure for quality, obtained from the C-arm (= used field size)
1 day
Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds]
大体时间:1 day
Measure for quality, obtained from the C-arm
1 day
Number and types of events
大体时间:1 day
Measure for quality, obtained from the C-arm
1 day

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 (预期的)

2022年5月1日

初级完成 (预期的)

2023年1月1日

研究完成 (预期的)

2023年2月1日

研究注册日期

首次提交

2022年2月3日

首先提交符合 QC 标准的

2022年2月3日

首次发布 (实际的)

2022年2月14日

研究记录更新

最后更新发布 (实际的)

2022年4月20日

上次提交的符合 QC 标准的更新

2022年4月12日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • NL.MUMC.ORCarms

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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