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临床试验/NCT03364062
NCT03364062Unknown不适用

A Multi-center Study on Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

Peking University People's Hospital0 个研究点目标入组 350 人开始时间: 2018年2月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
主要终点
Change from Baseline Systolic Blood Pressure

研究概览

简要总结

To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.

详细描述

A total of 350 cases of proximal humeral fracture are planned to be recruited and receive semi-shoulder replacement in Department of Orthopedics and Trauma,Peking University People's Hospital.The blood pressure data are collected from patients' anesthesia records. Both the systolic and diastolic blood pressure are recorded at four time spots during operation: the time before using of bone cement (time period A), 0-5 min after using cement (time period B), 5-10 min after using cement (time period C) and 10-15min after using cement (time period D). The data of blood pressure are collected according to anesthesia records.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement

排除标准

  • pathologic fracture
  • severe hypertension or hypotension

结局指标

主要结局

Change from Baseline Systolic Blood Pressure

时间窗: Change from Baseline Systolic Blood Pressure at 15 mins

the systolic blood pressure after insert the cemented stem

次要结局

  • Change from Baseline Diastolic Blood Pressure(Change from Baseline Diastolic Blood Pressure at 15 mins)

研究者

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

Zhang Peixun

Clinical Professor

Peking University People's Hospital

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