跳至主要内容
临床试验/NCT06050499
NCT06050499招募中不适用

Chemical Analysis of Limb Microfluidics

Imperial College London1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
Relative concentrations of key metabolites

研究概览

简要总结

Compartment syndrome (CS) is a condition where an increase in pressure in an anatomical compartment (e.g. the lower leg) affects the blood supply of the tissues, leading to tissue damage. The condition is difficult to diagnose, and more difficult to determine when and how to manage it.

Treatment aims to reduce the pressure in the compartment by whatever means possible. Surgical management by of CS is highly invasive and has associated risks including infection, damage to local structures (i.e. nerves), and possibly the inability to close the wound leading to the need for further reconstructive procedures.

The clinical challenge in suspected CS is knowing if and when to intervene. Some cases of mild CS may resolve without an operation, and therefore intervening too soon causes unnecessary harm to the patient. However, waiting too long to operate with high compartmental pressures may lead to irreversible damage to the tissues, resulting in either a useless limb or necrotic tissue needing amputation.

Current strategies for determining limb health include interrogation of symptoms, signs on examination, and serial measurements of compartmental pressures, but no absolute measurement of tissue health. As such, there is an element of clinical judgment in management and no evidence base with which to develop clear treatment guidelines. There is a need for a minimally invasive method of continuously monitoring tissue health to improve the understanding of CS and its management before significant improvement in patient outcomes can be delivered.

It is proposed the application of leg "microfluidics" - analysis of samples of leg fluid - in a series of predictable clinical scenarios which simulate the threatened and unsalvageable limb. This is with an ultimate aim of developing a method of limb fluid sampling that can predict if CS is present and requires intervention.

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

  • Adult patients (aged greater than or equal to 18 years) who are either:
  • i. Undergoing an intervention where there is a controlled reduction in blood flow to the limb that is reversible (e.g. using a tourniquet or clamp) or irreversible (e.g. during limb amputation).
  • ii. At risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team.

排除标准

  • Age <18 years old Unable to provide informed consent

结局指标

主要结局

Relative concentrations of key metabolites

时间窗: 20 minutes (real time analysis that takes 20 minutes to register from point of sampling to result)

Relative concentrations of key metabolites (glucose, potassium, lactate) in lower limb interstitial fluid, estimated against baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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