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临床试验/NCT05812352
NCT05812352已完成不适用

Evaluating Instructional Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study: A Randomized Controlled Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2023年1月24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
205
试验地点
2
主要终点
Correct tourniquet application at 6-month follow-up

研究概览

简要总结

It is unknown if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for bleeding control. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.

详细描述

Road traffic injuries (RTIs) are the largest contributor to the global trauma burden, which disproportionately affects low- and middle-income countries (LMICs). With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs, called lay first responders (LFRs). In prospective studies of LFR activity across three sub-Saharan African countries comprising 2,039 total patient encounters, LFRs most frequently provided hemorrhage control in 61% of patient encounters. Rapid hemorrhage control for compressible extremity hemorrhage by bystander LFRs has the potential to mitigate exsanguination, reducing mortality secondary to RTIs. Rapid hemorrhage control also has applicability to high-income country settings like the United States that sustain high rates of penetrating trauma due to gun violence. Rapid hemorrhage control using tourniquets for compressible extremity hemorrhage in patients not yet in shock is strongly associated with saved lives demonstrated in battlefield studies, decreasing preventable deaths by more than 50%. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for tourniquet application. Therefore, the investigators developed POC instructional interventions in response to the scalability challenges associated with in-person training to measure comparative effectiveness and skill retention using a randomized controlled trial design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor only enters the laboratory after the participant has attempted to apply the tourniquet. Therefore, the outcomes assessor is unaware of the instructional intervention that was employed. The outcomes assessor will assess (1) tourniquet placement sufficient distance above the injury defined as at least 2 inches proximal to the amputation, (2) turning on an external diaphragm pump that attempts to force water through tubing in the mannequin extremity bypassing the tourniquet.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Understand spoken and written English

排除标准

  • 未提供

结局指标

主要结局

Correct tourniquet application at 6-month follow-up

时间窗: 6 months

Number of participants who meet all criteria for correct application of the tourniquet

Correct tourniquet application at initial encounter

时间窗: After initial intervention (up to 20 minutes)

Number of participants who meet all criteria for correct application of the tourniquet

次要结局

  • Level of Participant Confidence at 6-month follow-up(6 months)
  • Level of Participant Confidence initially(After initial intervention (up to 20 minutes))

研究者

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

Zachary Eisner

Researcher

University of Michigan

研究点 (2)

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