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临床试验/NCT02240732
NCT02240732已完成不适用

Surgical Tourniquets and Cerebral Emboli Pilot Study

University Hospitals Coventry and Warwickshire NHS Trust1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Number of Emboli on Transcranial Doppler

研究概览

简要总结

BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England, Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative tourniquet can therefore help to improve the surgical field of view. Although the majority of surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are now not pursuing these devices.

There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet is used for TKR surgery. In addition embolic material in the venous system have been observed following TKR surgery and have been noted to be present in the right atrium with transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood. Fat embolism syndrome and post-operative confusion in TKR patients may be the result of emboli formed during a TKR. ,

AIM

  • Is there evidence of emboli entering the cerebral circulation following tourniquet deflation in TKR surgery?
  • Is there evidence of MRI detectable brain lesions and or any clinical change in cognition compared in patients undergoing TKR surgery with a tourniquet compared to those that do not have a tourniquet?

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • i.Aged >18
  • ii.Undergoing elective TKR
  • iii.Able to give written informed consent
  • iv.No contraindications to MR imaging

排除标准

  • i. Ages <16
  • ii. Not able to give written informed consent
  • iv. Contraindications to MR imaging

结局指标

主要结局

Number of Emboli on Transcranial Doppler

时间窗: Intra-operative

2 independent technicians will verify the number of emboli detected. Non-invasive

MRI brain scan - presence of Emboli

时间窗: Post-operatively, prior to discharge

Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions

次要结局

  • Mini-mental state examination(Pre-operative vs Post-operative)

研究者

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

Victoria Gibbs

Doctor

University Hospitals Coventry and Warwickshire NHS Trust

研究点 (1)

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