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临床试验/NCT02726594
NCT02726594Unknown不适用

Evaluation of Patient Comfort and Image Quality in Magnetic Resonance Imaging

University of Zurich1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Patient comfort

研究概览

简要总结

The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and to measure examination conditions and factors that may affect the image quality and thus the diagnostic accuracy. For this purpose a total of 1000 participants enrolled in the study, consisting of healthy volunteers (N = 300) as well as patients (N = 700), that are assigned to the clinically indicated MRI scan. In this study, individual regions of the body are studied by MRI (for example, knee, ankle, head or spine). For all participants of the study, the investigation for each region examined is exactly the same except that a single external factor is changed or is different. Such variable factors may include: the tube diameter of the magnet, weight of the coil, which is closely attached to the examined area of the body, the height adjustment of the table on which the participants lie, the duration of the study protocol and the generated volume during the investigation. Participants are involuntarily subjected to the particular MRI scanner and setting by availability of USZ Radiology disposition. For the evaluation of the data, participants will be matched in terms of the body regions being examined and based on being part of the patient or subject group. Due to the fine different experimental conditions, the influence of these factors on study patient comfort, as wells as the image quality and thus the diagnostic accuracy will investigated. By this approach, the relevant factors will be examined in isolation. Only by exploring the patient's perception/comfort during an MRI scan, the patient-orientated design of the study conditions can be improved and thus the possibilities of modern MRI technology can be fully utilized in clinical practice.

详细描述

Background: Magnetic resonance imaging ( "MRI") is an integral part of medical diagnostics since 20 years. Using MRI soft tissue imaging of body regions such as the brain, abdominal or musculoskeletal, is possible and is clearly superior to other imaging techniques. Due to the complex physical conditions a typical MRI scan will take 30-90 minutes (during which the patient should not do any movements), generates a noise level of 75-100 decibels and requires the placement of the patient in an often as cramped perceived tube scanner. These adverse conditions are not only known to have a significantly negative impact on the patient's comfort, but can also change the image quality and thus reduce the diagnostic accuracy of an investigation.

Motivation: At the University Hospital Zurich (USZ) a total of 10, partly very different MR scanners, are available for clinical imaging. These devices differ by the manufacturer and by the different design of the premises, the equipment, the coil and the table sizes, the logs up to the generated in the examination volume and the room temperature. For example, one of the existing examination rooms at the USZ has been equipped by a manufacturer with a costly patient comfort package. This room serves as a showroom and as a positive example for maximum patient comfort. Our experience shows that, overall, all the MRI scans of all units and the resulting image quality fluctuates greatly and the Patient Feedback for the individual studies is partly quite negative. Improved study conditions are therefore accessible both in terms of patient comfort and improved diagnostic accuracy, our goal.

Current status of research: The working group "Research in Musculoskeletal Radiology" at the Institute for Diagnostic and Interventional Radiology at the University Hospital Zurich is led by PhD Dr. med. Gustav Andreisek and under his authority already carried out successfully numerous projects in the field of magnetic resonance imaging.

Objectives: The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and to measure examination conditions and factors that may affect the image quality and thus the diagnostic accuracy. For this purpose a total of 1000 participants enrolled in the study, consisting of healthy volunteers (N = 300) as well as patients (N = 700), which are assigned to the clinically indicated MRI scan. In this study, individual regions of the body are studied by MRI (for example, knee, ankle, head or spine). For all participants in the study, the investigation for each region examined is exactly the same except that a single external factor is changed or is different. Such variable factors may include: the tube diameter of the magnet, weight of the coil, which is closely attached to the examined area of the body, the height adjustment of the table on which the participants lie, the duration of the study protocol and the generated volume during the investigation. Participants are involuntarily subjected to the particular MRI scanner and setting by availability of USZ Radiology disposition. For the evaluation of the data, participants will be matched in terms of the body regions being examined and based on being part of the patient or subject group. Due to the fine different experimental conditions, the influence of these factors on study patient comfort, as wells as the image quality and thus the diagnostic accuracy will investigated. By this approach, the relevant factors will be examined in isolation. Only by exploring the patient's perception/comfort during an MRI scan, the patient-orientated design of the study conditions can be improved and thus the possibilities of modern MRI technology can be fully utilized in clinical practice.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient comfort

时间窗: procedure

by questionnaires

次要结局

  • Image quality(procedure)

研究者

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

Gustav Andreisek

PD Dr. med.

University of Zurich

研究点 (1)

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