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临床试验/NCT01452425
NCT01452425已完成1 期

In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Intracompartmental Pressure (ICP)

研究概览

简要总结

Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication.

The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively.

The objective is to develop a model mimicking the physiopathology of MCS to assess the interest of the INVOS in this case.

详细描述

After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain a model of slight venous congestion and arterial hypoperfusion. A comparison will be made between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy volunteers
  • Informed consent

排除标准

  • Neuropathies
  • Vascular pathology
  • Actual pain
  • Anti-platelet or anticoagulant therapy
  • Ipsilateral history of fracture

结局指标

主要结局

Intracompartmental Pressure (ICP)

时间窗: 45 minutes

\[mean (SD)\] ICP (in mmHg), value at baseline and at the time of the block

Comparison Between INVOS Monitoring and Electromyography

时间窗: 45 minutes

A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block. Measures were: \[mean (SD)\] INVOS (in %) value at baseline and at the time of the block

次要结局

未报告次要终点

研究者

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

Forget Patrice

MD

Université Catholique de Louvain

研究点 (2)

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