Current Practice of Patients Undergoing C-arm Procedures at the Operating Department
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:
- What is the current practice and current time efficiency of C-arm procedures performed by radiodiagnostic technicians?
- What is the current quality of C-arm procedures operated by radiodiagnostic technicians?
研究概览
地位
条件
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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)?
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
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