Performance of Junctional Tourniquets in Normal Human Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effectiveness at Stopping Distal Pulse
研究概览
简要总结
Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.
详细描述
Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult human volunteers who are recruited, screened, and consent to participate
- •Ages at least 18 years old to no more than 60 years old (<61) on the date of consent
- •Male or female
- •A worker for the US Military or US Government (active duty military, civilian employees, contractors)
排除标准
- •Active-duty military subjects without their supervisor's permission to participate
- •Detainees or prisoners
- •Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease [uncontrolled hypertension, heart attack, or arrhythmias]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias
- •Pregnancy
- •Contracted employees to the US Military or US Government without contractual permission to participate in the research
研究组 & 干预措施
AAJT
Use of Abdominal Aortic and Junctional Tourniquet
干预措施: AAJT (Device)
JETT
Junctional Emergency Treatment Tool
干预措施: JETT (Device)
SJT
SAM Junctional Tourniquet
干预措施: SJT (Device)
CRoC
Use of Combat Ready Clamp (CRoC)
干预措施: CRoC (Device)
结局指标
主要结局
Effectiveness at Stopping Distal Pulse
时间窗: 1 min
Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.
次要结局
- Pain During Tourniquet Application(1 minute)
研究者
John F. Kragh, Jr, MD
Orthopedic Surgeon, Researcher
United States Army Institute of Surgical Research