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临床试验/NCT03218176
NCT03218176已完成不适用

Tourniquets Type Combat Application Tourniquet (CAT): Vascular Suffering According to the Proximal or Distal Location, Simple or Staggered. Study to Upper and Lower Limbs

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Lower limb : Pressure (mmHg) needed to abolish the pulse

研究概览

简要总结

A tourniquet is used to stop abundant bleeding when simple compression is not effective. The investigators will study the vascular suffering of the tourniquets according to their location on the limb: limb (arm / thigh) or distal (forearm / leg). Vascular suffering will be evaluated by the loss of the radial doppler flux for the tourniquets placed on the upper limb and in the tibial anterior to the lower limb by the loss of the pulse oximetry pulse and the collection of the signs described by the volunteers (pain, Paresthesia, cold sensation).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

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

  • Age greater than or equal to 18 years (major)
  • Volunteer to participate in research

排除标准

  • Age less than 18 years
  • Known coagulation disorder
  • Known vascular disorder
  • Known neurological disorder of the limbs
  • Known muscle disorders of the limbs
  • Presence of an implant in one of the limbs (vascular, contraceptive ...)
  • Simultaneous participation in research involving anticoagulant therapy
  • History of phlebitis
  • Persons of full age who are subject to legal protection (safeguard of justice, person placed in curatorship, guardianship), persons deprived of their liberty.
  • Pregnant women

结局指标

主要结局

Lower limb : Pressure (mmHg) needed to abolish the pulse

时间窗: 10 min

The main evaluation criterion for the inferior member is the pressure under the tourniquet, necessary to obtain an abolition of the anterior tibial pulse (measured in Doppler). By means of a balloon connected to a pressure gauge and fixed under each tourniquet, a measure of the pressure exerted (in mmHg) by the tourniquet (s) on the skin will be measured at laying. The comparison will be made for each type of pose (single vs stage) between the proximal and distal layers.

Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression

时间窗: 10 min

The main evaluation criterion for the superior member is the assessment of the pain felt according to the location of the tourniquets at the time of laying and at 10min. For the same location of tourniquet, the pain caused by the laying of one versus two tourniquets will be compared. For proximal versus distal, comparisons will be made for 1 tourniquet and for staggered tourniquets.

次要结局

  • Pulse oximetry(10 min)
  • Lower limb pain(10 min)
  • Upper limb pressure under tourniquet(10 min)
  • Loss of arterial Doppler pulse(10 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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