Surgical Tourniquets and Cerebral Emboli Pilot Study
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
- 是
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
Victoria Gibbs
Doctor
University Hospitals Coventry and Warwickshire NHS Trust
