Evaluating the Functionality of a Novel Layperson Tourniquet: A Doppler Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Successful occlusion
Study Overview
Brief Summary
This is a single-blinded, randomized clinical trial to determine if the Layperson Audiovisual Assist tourniquet's (LAVA TQ) ability to occlude arterial blood flow is non-inferior to that of the Combat Application Tourniquet (CAT).
Detailed Description
- Background and Significance
Trauma is the leading cause of death in the United States for people ages 1 to 44; uncontrolled bleeding is a leading cause of those deaths.1 Immediate hemorrhage control, even prior to the arrival of emergency medical services, can save lives during these emergencies. Since the launch of the Stop the Bleed (STB) campaign in 2015, the public has been empowered to stop life-threatening hemorrhage.2 One of STB's five objectives is to equip every bleeding control kit with audio and visual instructions; this has not yet been achieved. Commonly used tourniquets, such as the Combat Application Tourniquet (CAT) or Special Operations Forces Tourniquet (SOF-T), do not provide audio instructions and are not designed to provide feedback to facilitate tourniquet application. A device that could facilitate application and provide real-time instructions and feedback could be immensely beneficial to both the public and the DoD, especially to minimally or untrained people such as DoD civilians, contractors, and dependents on military installations. To achieve the above mentioned STB's objective, the research team at the National Center for Disaster Medicine and Public Health is devoted to develop a layperson tourniquet with audio-visual instructions and performance feedback.
In January 2020, the research team conducted a pilot study to evaluate this novel layperson tourniquet in a community lay public sample recruited from at the NBC Health Expo in Washington, DC. Findings of this pilot study were promising. One highlight of the results was that the proportion of participants who applied the tourniquet correctly using the layperson tourniquet was significantly higher than that using the CAT (93.3% versus 6.3%). Moreover, for when asked about their favoritism toward the tourniquet, 93.3% favored the novel layperson tourniquet, whereas 68.8% favored the CAT.
In addition to research results, feedback provided by the participants in this pilot study allowed the research team and the manufacturing partner to make adjustments and improvements to the testing device. Now we have completed a pilot study evaluating overall user experience of the novel layperson tourniquet, our next step is to conduct a functionality study examining the function of this novel layperson tourniquet and to see if it performs on par with the CAT. 2. Objectives/Specific Aims/Research Questions
The objective of the study is to determine if the Layperson Audiovisual Assist Tourniquet (LAVA TQ)'s ability to occlude arterial blood flow is non-inferior to a Combat Application Tourniquet (CAT). 3. Study Procedures
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The study population includes individuals with access to the USU campus and prior tourniquet experience (an individual has received tourniquet training previously or has used tourniquet before so that they would understand the discomfort when a tourniquet is applied).
Exclusion Criteria
- •Individuals with the following conditions or history will be excluded from participation: hypertension, prior vascular surgery, peripheral vascular disease, diabetes, prior lower extremity vascular surgery, active lower extremity infection, any hypercoagulable condition (such as Factor V Leiden, or Protein C and S deficiency), pregnancy, or any condition in which the participant is concerned they may suffer harm from brief tourniquet application.
Arms & Interventions
Layperson Audiovisual Assist Tourniquet (LAVA TQ)
For participants in the experimental arm, the Layperson Audiovisual Assist Tourniquet (LAVA TQ) is the first tourniquet applied to their leg as the intervention.
Intervention: Layperson Audiovisual Assist Tourniquet (LAVA TQ) (Device)
Layperson Audiovisual Assist Tourniquet (LAVA TQ)
For participants in the experimental arm, the Layperson Audiovisual Assist Tourniquet (LAVA TQ) is the first tourniquet applied to their leg as the intervention.
Intervention: Combat Application Tourniquet (Device)
Combat Application Tourniquet (CAT)
For participants in the control/active comparator arm, the Combat Application Tourniquet (CAT) is the first tourniquet applied to their leg as the intervention.
Intervention: Layperson Audiovisual Assist Tourniquet (LAVA TQ) (Device)
Combat Application Tourniquet (CAT)
For participants in the control/active comparator arm, the Combat Application Tourniquet (CAT) is the first tourniquet applied to their leg as the intervention.
Intervention: Combat Application Tourniquet (Device)
Outcomes
Primary Outcomes
Successful occlusion
Time Frame: While tourniquet is applied to leg (application 1)
Successful occlusion of blood flow is indicated by the absence of the dorsalis pedis pulse, as measured by a Doppler ultrasound.
Secondary Outcomes
- Applied pressure(While tourniquet is applied to leg (application 2))