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临床试验/NCT02608541
NCT02608541已完成不适用

Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Acute Pain

研究概览

简要总结

An observational study to derive clinically relevant and predictive rib fracture classification systems, based on retrospective and prospective cohorts, incorporating assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation

详细描述

The aim of this study is to derive radiology-based classifications of rib fractures and to test whether such classifications have a value in the prediction of clinical outcomes and patient reported outcome measures. The first aspect of work is to analyse existing radiology investigations (plain chest radiography (CXR) and derive classifications of rib fractures that, in the retrospective cohort of operated and non-operated cases, could have potential value in the guidance of management and prediction of clinical outcomes. The second aspect will be to evaluate the feasibility of collection of Patient Reported Outcome Measures in patients suffering multiple rib fractures, which will be used to assess the impact of the radiological classifications. The indications for surgery will remain according to current clinical practice and the management algorithms that have been developed previously in the department.

研究设计

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

入排标准

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

入选标准

  • Multiple simple rib fractures
  • Flail chest

排除标准

  • 未提供

结局指标

主要结局

Acute Pain

时间窗: up to 2 years

Visual Analogue Score

次要结局

  • Complications during critical care unit stay(up to 1 year)
  • Length of critical care unit stay(up to 1 year)
  • Length of hospital stay(up to 1 year)
  • Quality of Life - SF36 (Short Form 36)(up to 2 years)
  • Forced Expired Volume in 1 second (FEV1)(up to 2 years)
  • Forced Vital Capacity (FVC)(up to 2 years)
  • Complications during hospital stay(up to 1 year)
  • Quality of Life - EQ5D(up to 2 years)
  • Quality of Life - EORTC (European Organisation for the Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire - Cancer-30)(up to 2 years)
  • Quality of Life - EORTC QLQ-LC13 (Lung Cancer13)(up to 2 years)
  • Healthcare cost(up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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