PI: Robert C. Rankins, MD Lead Engineer: Adam Ewing Report Prepared by: Robert C. Rankins, MD and Ron Roubique, RN This testing and evaluation was performed using facilities and expertise available to RCR Medical Products, LLC, McKinney, TX. EXECUTIVE SUMMARY Introduction: Tourniquets have been used for thousands of years to control extremity bleeding, reduce and control blood flow. Extremity hemorrhage remains one of the most prevalent causes of death on the battlefield (Kelley, 2005). Hemorrhage is also the leading cause of preventable death in mass shootings. Now not only does the soldier or police officer need to have access to a tourniquet but the general public as well. Due to the unique design and functionality of the X8T Tactical tourniquet we wanted to compare it to currently available tourniquets and assess the effectiveness and suitability of the device for use on the battlefield and with the general population. Methods: Characterize and assess tourniquets in a controlled lab environment utilizing criteria developed at the DoD Tourniquet Summit in 2010. Phase I consisted of two sub phases. Sub phase Ia confirmed that all test and measurement equipment was calibrated, functioning as intended, and that all testers were trained to accurately and effectively apply the tourniquet on the test mannequin platform. All timing for application was started with the tourniquet ready to be positioned on the mannequin without any tightening having been performed. Sub Phase Ib followed with the assessment and data collection of the tourniquet's performance while utilizing the MATT tourniquet training mannequin. The methodology and process used in our testing and comparison was derived from testing that had been done in 2012 by the Naval Medical Research Unit. Results: A total of eight different models of tourniquets were tested and evaluated. The data for some of the tourniquets was obtained from testing done at the Naval Medical Research Unit in San Antonio and will be noted. Observations of device performance were noted throughout testing, highlighting the devices’ ability to perform in a safe, effective, and timely manner. Conclusions: Controlled metrics were used to assess the effectiveness and suitability of the X8T Tactical tourniquet device for its ability to provide safe, easy, and timely hemorrhage control. Testing the tourniquet device in a controlled setting will benefit comparisons by removing variables associated with field testing and provide metrics to give a better understanding of the device as designed. The results of this study will provide insight on the tourniquets ability to be a safe, effective, and timely hemorrhage control device for use with military, first responders and the lay public as well. 1. INTRODUCTION Tourniquets have been used for thousands of years to control extremity bleeding and reduce and control blood flow. Extremity hemorrhage remains one of the most prevalent causes of death on the battlefield (Kelley, 2005), and now is the leading cause of preventable death in mass shootings. Due to the unique design and functionality of the X8T Tactical tourniquet we wanted to compare it to currently available tourniquets and assess the effectiveness and suitability of the device for use with not only military, and law enforcement, but also within the public sector. This effort will assess currently- fielded tourniquets as well as the X8T. The RCR Medical products evaluation will consist of two parts. The first part will validate the requirements for efficacy, as determined by the March 2010 DOD Tourniquet Working Group. This part will be conducted in a laboratory setting and consist primarily of comparing the aspects of each tourniquet and documenting if they meet the requirements set forth by the DOD Tourniquet Working Group. This will be subpart 1a. Tourniquets under evaluation will be the B.OA. Tactical tourniquet, CAT, SOFTT-W, M2 Ratcheting (combat version), EMT, MET, and SWAT-T. Phase I will be broken into two subparts. Subpart Ia will ensure that all test equipment is functioning as intended, and that all testers can accurately and effectively apply the tourniquets on the test mannequin platform. Device specifications will be noted in the Specification Requirements Data Collection Sheet. Subpart Ib will include the assessment and data collection of each tourniquet’s performance while under test on the MATT mannequin. Phase I, evaluation of the B.O.A. Tactical tourniquet in its entirety, will be conducted at the Facilities of RCR Medical Products, McKinney, TX. Some other tourniquet data was collected at the Naval Research Unit in San Antonio, TX. as noted. All results obtained were compared with the results obtained at the Naval Research Unit. The goal was to create a spreadsheet that would allow for more easily comparing the different aspects of each tourniquet and in particular the B.O.A.. 2. MATERIALS AND METHODS 2.1 Test Equipment Descriptions of equipment items and devices under evaluation are derived from publicly- available manufacturer or distributor sources. MULTIPLE AMPUTATION TRAUMA TRAINER (MATT)™ SERIES 1500 TRAUMA SIMULATOR – TRAUMAFX™ The Multiple Amputation Trauma Trainer (MATT)® is a ruggedized, tetherless, remote controlled trauma trainer that delivers high fidelity simulations of lower body injuries commonly caused by IEDs and other explosive devices. Jointly developed by KGS and the U.S. Army Research Laboratory Simulation and Training Technology Center (ARL-STTC), MATT employs state-of-the-art special effects materials and technologies to deliver incredibly realistic visual and tactile stimuli with lifelike response to treatment. State of the art sensor technology provides real-time feedback that takes the guesswork out of trauma simulation training.
Figure 1: MATT™ mannequin EQUIPMENT UNDER COMPARISON (EUC) (IN NO PARTICULAR ORDER) X8T Tactical Tourniquet (X8T)™ The X8T Tactical tourniquet (figure 2) is the result of 2+ years of research and design based on hands on experience and use of other tourniquets on the market. Engineering was focused on ease of use and functionality. The end result is the only tourniquet available that meets or exceeds every requirement set by the DOD tourniquet working group in 2010. Easy to operate with one hand, whether in gloves, in wet or dark conditions. First strap tightening is easy and quick. The patented windlass dial allows for incremental adjustments in pressure of 5 mmHg per click avoiding having to over tighten a tourniquet and cause additional tissue damage.
Figure 2: X8T Tactical Tourniquet
Combat Application Tourniquet® (CAT)
The Combat Application Tourniquet® (CAT) (Patent Pending) (Figure 3) is a small and lightweight one-handed tourniquet that completely occludes arterial blood flow in an extremity. The CAT uses a Self-Adhering Band and a Friction Adaptor Buckle to fit a wide range of extremities combined with a one-handed windlass system. The windlass uses a free moving internal band to provide true circumferential pressure to an extremity. The windlass is then locked in place; this requires only one hand, with the Windlass Clip™.
The CAT also has a Hook-and-Loop Windlass Strap™ for further securing of the windlass during patient transport.
Figure 3: CAT Tourniquet
SPECIAL OPERATIONS FORCES TACTICAL TOURNIQUET – WIDE (SOFTT-W)
The Special Operations Forces Tactical Tourniquet-Wide (SOFTT-W) (Figure 4) is the result of an exhaustive 24 month research initiative compiling end-user research and laboratory studies to develop a more effective, easier to use tourniquet for all environments. High-strength, lightweight alloy components are used in critical areas of function ensuring reliability in the most challenging of circumstances and on the largest of limbs. With a true 1-1/2” tourniquet strap and a quick-connect buckle that eliminates the need to ever re-thread the strap, application is faster and easier.
Features:
● A true 1 ½” constricting band for increased constricting pressure and comfort.
● Quick-release, snap-lock buckle design, allowing rapid re-routing of the band around trapped limbs without rethreading
● Lower-profile, lighter weight alloy components, providing the required strength and durability only metal can offer
● Single application method regardless of location
● 25% lighter than the current SOFTT and reduced size for easier storage
Figure 4: SOFTT-W Tourniquet M2 RATCHETING MEDICAL TOURNIQUET™ (COMBAT VERSION) The Ratcheting Medical Tourniquets™ (RMT™) (Figure 5) control life-threatening extremity bleeding. The only self-locking tourniquet. Compact, lightweight, and rugged. ‘Easily’ applied with one hand. Simple, intuitive ‘glove’ operation Activation requires ‘only’ unidirectional gross motor skills.
Figure 5: M2 Ratcheting Medical Tourniquet™ (Combat) EMERGENCY & MILITARY TOURNIQUET (EMT) Delfi’s state-of-the-art Emergency & Military Tourniquet (Figure 6) was designed to combine a high level of tourniquet safety with durable portability. In ground-based tactical situations and pre-hospital settings, the tourniquet is used as a life-saving hemorrhage control device. Based on proven surgical tourniquet designs, the Delfi E.M.T. completely stops blood flow, is fast and simple to self-apply, and requires minimal training.
Figure 6: Emergency & Military Tourniquet (EMT) Military Emergency
Military Emergency Tourniquet (MET)
The professionals at Tier-One Quality Solutions™ (TQS™) understand this reality and have designed the industry’s most reliable tourniquet device, the Military Emergency Tourniquet™ (MET™) (Figure 7).
Successfully tested and evaluated by the U.S. Navy’s Experimental Diving Unit, the MET™ rapidly and reliably provides lifesaving pressure in the event of critical uncontrolled hemorrhage.
Figure 7: Military Emergency Tourniquet (MET) SWAT-TOURNIQUET™ The SWAT-Tourniquet™ (SWAT-T™) (Figure 8) is a durable tourniquet. It has been advanced aged and heat/cold tested. The SWAT-T™ has an extended shelf life to 5 years. The SWAT-Tourniquet™ is a unique and multipurpose dressing. Its name provides a description for usage Stretch, Wrap, and Tuck, but also the communities for whom it was developed - military and civilian Special Weapons and Tactics teams.
Figure 8 SWAT-T Tourniquet TEST PROCEDURES PART IA ● Basic assessment of the physical characteristics of the tourniquet devices. ● Training to ensure the test team can accurately place and use the tourniquets. Basic assessment of the physical characteristics of the tourniquet devices. This information is recorded on the Specification Requirements Data Collection Sheet. These requirements were taken from the DOD Tourniquet Working Group list of Requirements. ● Food and Drug Administration (FDA) Registration- Verify and record FDA registration provided from tourniquet manufacturer. ● Width ≥ 1.5 in- Took measurements of tourniquet from the portion of the band which will distribute pressure required to control hemorrhage. These measurements were acquired using Fowler ULTRA-CAL Mark III electronic calipers. ● Length ≥ 37.5 in- This measurement was acquired by laying the tourniquet flat and measuring from end to end. An effective length was also recorded by securing the tourniquet at the outermost length where the tourniquet can be used. The circumference was measured and recorded. ● Weight <8oz- Weight was measured on Ohaus Dial-O-Gram scales. Weight was recorded as packaged from manufacture. The weight was also recorded of the unpackaged device. ● Cubic Size ≤ 25.6 in³- Measurements of the height, width, and length of the packaged device was recorded. These measurements produce a cubic footprint but not the actual cubic displacement. ● Color (subdued)- Yes/No answer as to whether the unpackaged device was subdued in color or consisted of colors that are non-subdued. ● Protective Packaging- Is the device packaged to protect from environmental elements? ● Tracking/Date of Manufacture Information- Was there tracking information present? Was the information printed on the device or the packaging? ● User Instructions Present- Were there user instructions present? If so, was the information printed on the device or the packaging? ● Latex-free Components- Does the manufacture specify the device is Latex Free or not? ● Material Component Standards- Is there information available to specify if the device was manufactured using Military Specification Standards? ● Single Patient Use- Does the device information state that the device is intended for single patient use? PART IB ● Assess the efficacy of the X8T (B.O.A.) tourniquet under evaluation, as applied to the MATT™ mannequin. RCR Medical Products used the same definitions and measurements as was used in the Naval Medical Research Units work in 2012 in order to have numbers that could be compared fairly. ● The tourniquet was evaluated for safety concerns, whether in design or application Basic assessment of the efficacy of the tourniquet devices. Table 1 compares all the tourniquets used in the study based on the desired criteria set forth by the DOD in 2010 by the tourniquet working group. ● Application efficacy of manufacturer instructions - Did the tourniquet device apply according to manufacturer's instructions? ● Number of turns/wraps/ratchets - Indication of the amount of turns on the windlass handle. 180° of windlass rotation counts as 1 turn. Wraps indication shows number of revolutions the device had on the test platform. Ratchets are the count of individual clicks the device made during application. ● Occlusion of Vessel (Visual) - On the MATT mannequin this was indicated by the flow stoppage. ● Occlusion of Vessel (Pressure) - On the MATT mannequin the loss of audible Doppler signal indicates vessel occlusion and a “Good” application. ● Time to Tighten – Is the measured time required to tighten the tourniquet after the tourniquet in place. ● Breakage of Device – Did the device break? ● Deformation of Device – Did any of the parts of the tourniquet deform while being applied? ● Breakage Occurred Number of Turns/Wraps/Ratchets – If breakage occurred, at what stage did the breakage occur in the application process? ● Sustained Occlusion Over Time – Did the tourniquet maintain occlusion? Recorded in increments of 15 sec, 30 sec, 45 sec, and 60 sec. Assess the X8T Tourniquet for Safety Concerns, Whether in Design or Application. · Is the tourniquet safe during application? Does the design of the tourniquet pose a safety issue where injury may result during the application of the device? · The tourniquet’s ability to stay secure once applied. The chance of the tourniquet loosening or failing after application could result in a loss of life. RESULTS DATA COLLECTION Basic assessment of the physical characteristics of the tourniquet devices. Chart 1 shows a summary of the individual tourniquet groups taking the average of 5 devices. The entries shown in red fall outside suggested parameters.
Chart 1: Assessment Summary of the Physical Characteristics. *now called the X8T.
All data was collected at RCR Medical Products and compared to that collected by the Naval Medical Research Unit. Data marked with ^ indicates only Naval Medical Research Unit data.
Basic assessment of the efficacy of the tourniquet devices. Chart 2, shows the performance data collected by RCR Medical Products and compared to data collected by the Naval Medical Research Unit, San Antonio, TX except for the X8T. This data was acquired during the performance phase.
Chart 2: Assessment Summary of Performance.
Tourniquet Resolution Mechanical tourniquets use various methods for tightening. The most common is the windlass. The windlass operates by twisting a strap inducing shortening of the strap and thereby causing constriction of the tourniquet. We found that there were considerable differences in tourniquets with the same basic design secondary to strap width and thickness. The SOFT-T was much more difficult to tighten after just one to two revolutions than was the CAT. This was because of the wider strap in the windlass. The ratcheting tourniquets have a smaller step increases in pressure with each movement of the mechanism and thereby make it easier to tighten to a point. The problem we ran into with the RMT was it was difficult to operate as it neared the appropriate tension. It will be of interest to see how well this functions in gloved hands and in the cold. The pneumatic style tourniquets function like the standard blood pressure cuff and are easy to operate secondary to the small increments in pressure created with each squeeze of the bulb. The X8T uses a windlass dial that has 20 incremental steps through a rotation of 360 degrees. This allows for single handed use and small increases in pressure with each step, however with the design of the unit it is easily rotated quickly to allow for rapid adjustment as well. The importance of resolution. The finer the resolution the easier the tourniquet is to apply. The key to having better resolution lies in the amount of incremental pressure control the user has with each tourniquet. By design, the tourniquet device can have from fine to coarse pressure control. The windlass tourniquets tested increase pressure on average of 58mmHg per revolution, the ratchet types increased an average of 22mmHg per ratchet (Naval Medical Research Unit 2012). The pneumatic types are able to increase the pressure from 1 to 6mmHg depending on the amount the bulb is squeezed (Naval Medical Research Unit 2012). The X8T increases pressure by 3 mm Hg with each click of the dial. The ability of controlling the applied pressure will increase the safety of these devices and the ability to obtain occlusion with the minimum required pressure. CONCLUSIONS The objective of this study was to provide a detailed comparison of tourniquet baseline data according to the consensus criteria generated at the 2010 DoD Tourniquet Group. Most of the Part II results matched very closely with the data collected by the Naval Medical Research Unit on the same products. The users in our study could not obtain occlusion with the SOFT-T and get the units windlass into a position to secure it. It was also found very difficult to twist after the first turn secondary to the bar wanting to skew sideways on the user. The RMT was found to be applied quickly once the user had several practice attempts and was more familiar with the mechanism. The SWAT never was close to stopping the blood flow on the mannequin. The X8T consistently was placed and secured in under 13 seconds even on first use. The X8T was applied and secured in less than half the time of all the other tourniquets used in the study and was much more intuitive for the user. The information provided in this report will aid in the comparison of current and future tourniquet devices. Acknowledgment – Disclaimer This study was performed at the offices of RCR Medical Products, LLC and under the direction of Robert C. Rankins, MD, FACEP. RCR Medical Products is the sole manufacturer of the X8T tourniquet. We encourage and look forward to other studies being done to validate the results we have found.