跳至主要内容
临床试验/NCT03538379
NCT03538379Unknown不适用

Evaluation of Hemorrhage Control and Tourniquet Training Effectiveness for Laypersons

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
34
试验地点
2
主要终点
Correct Tourniquet Application

研究概览

简要总结

Trauma is the leading cause of death for individuals ages 1-45 years old, within this cohort, and uncontrolled hemorrhage is the leading cause of preventable death.1,2 Tourniquets have been shown to be effective in dramatically decreasing death from uncontrolled hemorrhage on the battlefield and there is level 4 evidence that EMS application of tourniquets in the civilian sector is effective though not to the same degree as in the military.3,4 Multiple national groups have advocated that to further decrease preventable deaths from hemorrhage, laypersons should apply tourniquets before the arrival of professional first responders. To this aim, the "Stop the Bleed" campaign has trained over 100,000 individuals in the US in hemorrhage control techniques and tourniquet use with the Bleeding Control Basic (B-Con) course.5 The "Stop the Bleed" campaign informs course participants all commercial tourniquets are equivalent, and improvised tourniquets should be applied if a commercial tourniquet is not available.6 The investigators are evaluating the ability of the B-Con course participants to apply three different types of commercial tourniquets, the Rapid Application tourniquet (RAT), the Stretch-Wrap-And-Tuck tourniquet (SWAT-T), and the Sof Tourniquet (Sof-T) as well as participants ability to fashion an improvised tourniquet. The investigators hypothesize B-Con in its current form does not enable course participants to apply other commercial tourniquets beyond the specific one taught, the CAT tourniquet, and does not teach how to apply an improvised tourniquet.

详细描述

Hemorrhage control by rapid application of commercial tourniquets has significantly improved the survival of military personnel injured on the battlefield.7,8 The U.S. civilian population has seen a spike in battlefield like injuries in the recent years, a prime example being the Boston Marathon bombing.9,10 To address this issue, the American College of Surgeons (ACS) formed a committee comprised of individuals from the fields of healthcare, law-enforcement, fire department, pre-hospital care and the military. This committee came up with a set of recommendation regarding first response and capacity building for hemorrhage control, known as the Harford Consensus.11 These recommendations include educational programs for lay-people in hemorrhage control with an emphasis on rapid and early tourniquet application. There is level 4 evidence that after adjustment for covariates, emergency medical providers' application of tourniquets in civilian trauma decreases mortality, though not to the same dramatic degree seen in the military setting.12-14 Researchers are working to show the effect of training of laypersons in hemorrhage control in the real world but no data beyond the simulation setting is currently presented in the literature.15 Various groups have developed training programs for hemorrhage control training, the most notable of which is the ACS "Stop the Bleed" Bleeding Control Basic (B-Con) training.16 B-Con has trained over 100,000 individuals in the US since its implementation.5 Goralnick et. al. have shown that there is moderate retention for the retention of B-Con specifically for application of the Combat Application Tourniquet (CAT), which is also the type of tourniquet with the best evidence for its use as it is the type used by the US military.17 However, the Hartford consensus and the "Stop the Bleed" campaign state that "(1) commercial windlass-type tourniquets should be used in the prehospital setting for the control of significant extremity hemorrhage when direct pressure is ineffective or impractical, (2) improvised tourniquets should be used only if no commercial device is available."5,18 This advocacy for types of commercial tourniquets beyond the CAT and, more significantly, for improvised tourniquets has not been studied in either a simulated or real setting.

There are multiple different tourniquet types available for which, while the principle is the same for all, the actual mechanism and steps for application vary. B-Con in its current iteration informs participants the principle is the same for both other commercial tourniquets and improvised tourniquets, which is to be tight enough to occlude arterial bleeding. Other courses which have been widely disseminated have taught how to use tourniquets other than the CAT, such as the Stretch-Wrap-And-Tuck tourniquet (SWAT-T).19 Currently, the courses being offered typically only teach how to use one, and sometimes two, different types of tourniquets. Furthermore, as there is not broad consensus statement about which tourniquet type to use and teach, different groups distribute different types of tourniquets in publicly available bleeding control kits, and professional first responders carry different types of commercial tourniquets. A randomized trial has shown that among some of the available commercial tourniquets, the CAT, ratcheting medical tourniquet (RMT), and SWAT-T, the proportion of application for those without training ranges from 10.6-23.4%.

The B-Con course presumption that participants understand tourniquet principles rather than a single technique, which would enable them to apply devices they have not seen before, has not been evaluated. In this context, the investigators would evaluate participants, immediately after completing the full B-Con course, on their ability to apply different commercial tourniquets than what they were trained on and their ability to apply a commercial tourniquet.

  1. Study design:

a) Prospective open-label trial 2. Consent:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
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

  • Participation in the Bleeding Control Basic Course

排除标准

  • 未提供

研究组 & 干预措施

Combat Application Tourniquet (CAT)

Active Comparator

The combat application tourniquet (CAT) is the type of commercial tourniquet taught in the B-Con course as administered by the investigators. It will serve as the control group to which all other types of tourniquets, which are not explicitly taught in the course, are compared to.

干预措施: Bleeding Control Basic (B-Con) Course (Behavioral)

Sof Tourniquet (Sof-T)

Active Comparator

The Sof-Tourniquet (Sof-T) is a commercial windlass type tourniquet similar to the CAT tourniquet in that it is based on a windlass mechanism. Its application not explicitly taught in the B-Con course.

干预措施: Bleeding Control Basic (B-Con) Course (Behavioral)

Stretch-Wrap-And-Tuck (SWAT) Tourniquet

Active Comparator

The Stretch-Wrap-And-Tuck (SWAT) Tourniquet is a commercial elastic tourniquet. Its application not explicitly taught in the B-Con course.

干预措施: Bleeding Control Basic (B-Con) Course (Behavioral)

Improvised Tourniquet

Active Comparator

The improvised tourniquet arm will involve participants being given supplies to enable them to fashion a tourniquet. The supplies will include a leather belt, gauze, shoestring, and a rod to act as a windlass.

干预措施: Bleeding Control Basic (B-Con) Course (Behavioral)

Rapid Application Tourniquet (RAT)

Active Comparator

The Rapid Application Tourniquet (RAT) is a commercial elastic tourniquet similar to a bungee cord. Its application not explicitly taught in the B-Con course.

干预措施: Bleeding Control Basic (B-Con) Course (Behavioral)

结局指标

主要结局

Correct Tourniquet Application

时间窗: Within 30 minutes of completing training

Correct tourniquet application for each type of tourniquet tested. Correct application for all arms / types of tourniquets is defined as application pressure \> 250 mmHg, distance above injury of \> 2 inches, and time to application \< 2 minutes.

次要结局

  • Total Blood loss(Within 30 minutes of completing training)
  • Time to Tourniquet Application(Within 30 minutes of completing training)
  • Pressure Applied by Tourniquet(Within 30 minutes of completing training)
  • Demographic Predictors of Correct Tourniquet Application(Within 30 minutes of completing training)
  • Willingness-to-assist in Emergency(immediately before training and within 30 minutes of completing training)
  • Comfort level Controlling Hemorrhage(immediately before training and within 30 minutes of completing training)

研究者

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

Eric Goralnick

Assistant Professor

Brigham and Women's Hospital

研究点 (2)

Loading locations...

相似试验