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临床试验/NCT04870814
NCT04870814已完成不适用

Comparison of 4 Tactical Tourniquets Used in War Medicine

Direction Centrale du Service de Santé des Armées2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
Time required to apply the tactical tourniquet.

研究概览

简要总结

Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage.

Currently, most Western armed forces recommend the use of the tactical tourniquet in combat for the management of tourniquetable hemorrhage.

The SOFTT® tourniquet (Tactical Medical Solutions, Anderson) is the tactical tourniquet currently in use by the French armed forces. As the contract will soon come to an end, the question of its renewal arises.

The purpose of this study is to compare 4 commercially available tactical tourniquets in healthy volunteers.

The hypothesis of the research is that one of the 4 tourniquets compared is faster to set up than the others.

研究设计

研究类型
Interventional
分配方式
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 ≥ 18 years;
  • Student of the Military Health School of Lyon Bron (Ecoles Militaires de Santé de Lyon Bron; EMSLB);
  • Periodic medical examination up to date with the mention "fitness for duty";
  • Holder of the "Combat Rescue Level 1" training.

排除标准

  • Vascular pathology;
  • Current progressive pathology of any kind;
  • History of thrombo-embolic disease;
  • Presence of cardiovascular risk factors (diabetes, hypertension, dyslipidemia, smoking > 1 cigarette/day, BMI > 25);
  • Iliofemoral and axillary vascular abnormalities detected by systematic Doppler ultrasound;
  • Presence of symptoms suggestive of COVID-19;
  • Positive COVID-19 antigen test;
  • In contact with a person diagnosed positive for COVID-19 within 15 days prior to inclusion;
  • Pregnant or breastfeeding woman.

结局指标

主要结局

Time required to apply the tactical tourniquet.

时间窗: Each day during 4 consecutive days

The tourniquet application time, in seconds, measured with a stopwatch. The stopwatch will be started when the fitter takes the tourniquet, pre-positioned in a tourniquet pouch on his bullet vest. The stopwatch will be stopped as soon as at least one of the following conditions is verified * the fitter judges the fitting to be effective * the fitter cannot tighten any more (technical limit) * the tourniquet is too painful for the receiver.

次要结局

  • Rusticity of the tactical tourniquet(Each day during 4 consecutive days)
  • Pain experienced by the receiver during application of the tactical tourniquet(Each day during 4 consecutive days)
  • Occlusion of the downstream arterial flow following after tactical tourniquet application(Each day during 4 consecutive days)
  • Ease of use of the tactical tourniquet(Each day during 4 consecutive days)
  • Stability of the tactical tourniquet(Each day during 4 consecutive days)

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (2)

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