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临床试验/NCT06464289
NCT06464289已完成不适用

Surgical Stabilisation of Rib Fractures in Non-ventilated Patients: a Retrospective Propensity-matched Analysis Using the Data From the German National Trauma Registry (TraumaRegister of the German Trauma Society (DGU))

University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 35,974 人开始时间: 2024年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35,974
试验地点
1
主要终点
Duration of intensive care unit stay.

研究概览

简要总结

The aim of the study is to investigate the effect of surgical stabilisation of rib fractures on clinical outcomes in patients that are not dependent on mechanical ventilation at the time of the treatment decision. To this end, data on all eligible patients will be extracted from the TraumaRegister® DGU. Baseline demographics will be analysed using descriptive statistics. Propensity matching will be conducted between the operative cohort (receiving SSRF by any technique) and the conservative cohort (not receiving SSRF). The effect of SSRF on the outcome variables will then be assessed using appropriate statistical tests.

研究设计

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

入排标准

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

入选标准

  • Rib AIS of ≥ 3
  • Initial hospital treatment

排除标准

  • Intubated preclinically or in the emergency department
  • Glasgow coma scale (GCS) < 9 at the time of the primary survey in the emergency department
  • No in-patient hospital management

结局指标

主要结局

Duration of intensive care unit stay.

时间窗: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

The duration in days a patient spent in the intensive care unit from the time of hospital admission to the time of initial hospital discharge.

In-hospital mortality

时间窗: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

Number of patients who died in the hospital and mortality rate up to hospital discharge

Duration of mechanical ventilation

时间窗: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

The duration in hours a patient spent intubated from the time of hospital admission to the time of initial hospital discharge

次要结局

  • Rate of respiratory failure(From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.)
  • Rate of single organ failure(From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.)
  • Proportion of patients intubated at any time(From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.)
  • Rate of multiorgan failure(From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.)
  • Rate of sepsis(From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.)
  • Duration of hospital stay(From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.)
  • Clinical outcome(At the time of initial hospital discharge or death, whichever came first, assessed up to 2 month.)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Sponsor

研究点 (1)

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