NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

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1 NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO JOINT OPERATIONAL EVALUATION OF FIELD TOURNIQUETS (JOEFT) PHASE II RENE ALVAREZ, PHD, D. DUANE COX, AND ROY DORY, MS EXPEDITIONARY AND TRAUMA MEDICINE DEPARTMENT COMBAT CASUALTY CARE AND OPERATIONAL MEDICINE DIRECTORATE NAMRU-SA REPORT # DISTRIBUTION C Government only and contractors Distribution Statement C: Distribution authorized to U.S. government agencies and their contractors. Refer other requests for this document to Naval Medical Research Unit San Antonio, Combat Casualty Care and Operational Medicine Directorate, Expeditionary and Trauma Medicine Department, 3650 Chambers Pass, Bldg 3610, JBSA, Ft Sam Houston, TX

2 DECLARATION OF INTEREST The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, nor the U.S. Government. This work was funded by work unit number G1021. The study protocol was approved by the Naval Medical Research Unit San Antonio Institutional Review Board in compliance with all applicable Federal regulations governing the protection of human subjects. The authors are employees of the US Government. This work was prepared as part of their official duties. Title 17 USC 105 provides that copyright protection under this title is not available for any work of the US Government. Title 17 USC 101 defines a US Government work as a work prepared by a military service member or employee of the US Government as part of that person s official duties. ACKNOWLEDGMENTS The authors would like to thank LCDR Anne McKeague, PhD USN for her technical assistance and input to the study. We would also like to thank Ashley Turnmire for her editorial support which was essential for completion of this effort. Page 1

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4 TABLE OF CONTENTS TABLE OF CONTENTS... 3 EXECUTIVE SUMMARY... 4 INTRODUCTION... 6 MATERIALS AND METHODS... 6 Volunteers... 6 Experimental Design... 7 Instrumentation... 7 Equipment Under Test... 8 Test Procedures RESULTS & DISCUSSION CONCLUSIONS REFERENCES ABBREVIATIONS Page 3

5 EXECUTIVE SUMMARY Background: Tourniquets have been used since antiquity to reduce and control blood flow at the extremity, as well as facilitate limb amputation. Extremity hemorrhage remains one of the most prevalent causes of death on the battlefield. Due to advances in technology and new tourniquet designs, the Department of Defense (DoD) has found it necessary to assess the effectiveness and suitability of emerging tourniquet devices for their ability to control extremity hemorrhage, withstand environmental conditions on the battlefield, and compare ease of use from training to actual battlefield applications. This report describes the second phase of an evaluation of field tourniquets by investigators at Naval Medical Research Unit San Antonio (NAMRU-SA). The Joint Operational Evaluation of Field Tourniquets (JOEFT) Phase I assessed current fielded tourniquets, as well as other Food and Drug Administration (FDA) registered tourniquets using previously established criteria. All safety and efficacy parameters evaluated on these tourniquets were reported in the JOEFT Phase I report (McKeague & Cox, 2012). Objective: Based on the results from Phase I, seven tourniquets advanced to Phase II testing to evaluate each tourniquet s efficacy in the hands of non-medical volunteer subjects. Tourniquets evaluated included: CAT, SOFTT-W, RMT-CBT, RMT-TAC, EMT, MET, and SWAT-T. Methods: Volunteers utilized either the mid-thigh of the HapMed Instrumented Leg for Tourniquet Training or the upper humerus of the HapMed Instrumented Arm for Tourniquet Training under four simulated field conditions:, simulated blood soaked, Darkness, or Darkness simulated blood soaked. Night Vision Goggles (NVG) were utilized to simulate blackout conditions. Phase II was divided into two sub phases: Phase IIa, evaluation of the seven tourniquets using the mid-thigh of the training instrument; and Phase IIb, evaluation of successful Phase IIa tourniquets using the upper humerus of the training instrument. Ten nonmedical volunteers participated in Phase IIa and eleven non-medical volunteers participated in Phase IIb. For each phase, an effective tourniquet was one that, when applied, achieved occlusion and held occlusion for one minute. Tourniquet failures were recorded if: 1) the device had critical malfunctions, deformations, or broke on application; 2) volunteers were unable to apply the device and reach occlusion within the five minute test period; 3) the device could not produce required occlusion pressure; or 4) the device did not maintain occlusion for one minute post-application. Tourniquets which produced >80% success rate in all four simulated field conditions in Phase IIa advanced to Phase IIb of the study. Page 4

6 Results: Of the seven tourniquets, five (CAT, SOFTT-W, RMT-CBT, RMT-TAC, and EMT) achieved >80% success throughout all four experimental conditions in Phase IIa, achieving proper application in an average time of (+22.96) seconds and were, therefore, eligible for Phase IIb. Of the five tourniquets evaluated in Phase IIb, all five tourniquets achieved >80% success throughout all four experimental conditions, achieving proper application in an average time of 52.5 (+28.8) seconds, with no observed breakages or deformities. Conclusions: Phase II test and evaluation, conducted at the hands of non-medical volunteer subjects, revealed noted differences in tourniquet function and ease of use. The CAT, SOFTT W, RMT CBT, RMT TAC, and EMT devices met the success criteria on both the HapMed Instrumented Leg and the HapMed Instrumented Arm, in all four simulated field conditions. The MET and SWAT devices both failed to achieve >80% success rates in all four experimental conditions due to both mechanical failures and the inability to achieve and maintain necessary occlusion pressure. These data generated on field tourniquets in a controlled, experimentally validated system will aid the sponsor in selection of devices aimed at controlling extremity hemorrhage on the battlefield. Page 5

7 INTRODUCTION Tourniquets have been used since antiquity to reduce and control blood flow at the extremity, as well as facilitate limb amputation. Extremity hemorrhage remains one of the most prevalent causes of death on the battlefield. The majority of battlefield injuries are reported to occur in extremities, and an estimated 7 out of 100 deaths attributed to these injuries would have been averted if a tourniquet had been properly applied (Mabry et al., 2000; Bellamy, 1984). Due to advances in technology and new designs of tourniquets, it has been necessary for the Military to assess the effectiveness and suitability of emerging tourniquet devices for their ability to control extremity hemorrhage, withstand environmental conditions on the battlefield, and compare ease of use from training to actual battlefield application. Previous studies, which examined devices and their design after use in a military operational setting, concluded that correct application is more critical than applied pressure; therefore, proper training is instrumental in insuring effectiveness of tourniquets (Kragh et al., 2011). The Joint Operational Evaluation of Field Tourniquets study assessed currently fielded tourniquets as well as other Food and Drug Administration (FDA) registered tourniquets. The study was defined by the results of the Department of Defense (DoD) Tourniquet Working Group Summit held in Quantico, Virginia in March The Defense Medical Material Program Office brought together experts after the Marine Corps received reports of failures of the Combat Application Tourniquet (CAT) during field use (USMC DTG: Z Jan 10). The CAT is the current recommended tourniquet in the Individual First Aid Kit (IFAK) of every Sailor, Soldier, Airman and Marine. During the Summit, experts agreed on consensus parameters to test for efficacy, safety, and operational effectiveness. The safety and efficacy parameters were recently tested at Naval Medical Research Unit San Antonio (NAMRU-SA) (McKeague & Cox, 2012), and only those shown to be safe and effective were selected to proceed with the operational testing covered under this protocol. MATERIALS AND METHODS Volunteers The study was conducted under an approved NAMRU-SA Institutional Review Board Protocol (NAMRU-SA ) in compliance with all applicable Federal regulations governing the protection of human subjects. Twelve individuals participated in the Phase IIa and Phase IIb tests and all were healthy adults ( 18-years old) with no formal medical training. Page 6

8 Volunteers were civilian and active duty personnel recruited from Fort Sam Houston and Brooks City Base, Texas. Gender, ethnicity, and other demographics were not recorded or used as exclusion criteria. Informed consent was obtained from each volunteer prior to participating in the study. Experimental Design Tourniquet test and evaluation was completed in two phases, with those tourniquets meeting the success criteria in Phase IIa moving on to Phase IIb. Each phase was a split-plot randomized block design, in which tourniquets were applied under four test conditions. The tourniquet was either dry or simulated blood soaked and applied with day or nighttime lighting. Volunteers applied each tourniquet in each of the four test conditions. Tourniquets were considered successful if they obtained occlusion within a five minute test period and maintained occlusion for a one minute period. Failures were recorded if: 1) a tourniquet had critical malfunctions, deformations, or broke on application; 2) volunteers were unable to apply the tourniquet and reach occlusion within five minutes; 3) device did not maintain occlusion for one minute post-application. Results were projected upon a binary space; hence, the tourniquet either met all success criteria for the test condition or did not. A power analysis indicated a minimum of ten participants would be required for the study, yielding a statistical power of 80% and a 0.66 coefficient of variation at a 95% confidence level. As a result, differences between any two tourniquets were considered significant when the number of successful trails differed by 5 or more (Hines & Montgomery, 1980). Instrumentation HapMed Instrumented Leg and Arm for Tourniquet Training. The HapMed instrumented Leg and Arm (Figure 1) provides stand-alone, hands-on skills training in which trainees can experience the actual torque required to stanch bleeding from an extremity wound and be timed on tourniquet application. Sensors within each device gauge the amount of pressure being applied and light emitting diodes indicate when bleeding has slowed and occlusion has been reached. Touch screen controls allow for user interface and include: 1) start and stop time for tourniquet application, 2) timed occlusion phase to insure adequate placement and performance of tourniquet, 3) bleeding period, 4) total blood loss, 5) number of tourniquets applied, and 6) location of tourniquets placed for accuracy in application. Page 7

9 Figure 1. HapMed Instrumented Leg and Arm Equipment Under Test The following tourniquets were tested. They are listed in no particular order. Combat Application Tourniquet (CAT). The CAT (Figure 2) is a small, lightweight onehanded tourniquet designed to occlude arterial blood flow in an extremity. The CAT uses a selfadhering band and a friction adaptor buckle to fit a wide range of extremities sizes, 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 can be locked in place one handed utilizing the Windlass Clip and further secured with a Hook-and-Loop Windlass Strap during patient transport. Figure 2. CAT Tourniquet Page 8

10 Emergency & Military Tourniquet (EMT). The EMT (Figure 3) was designed to combine a high level of tourniquet safety with durable portability. Based on proven surgical tourniquet designs, the EMT was designed to completely stop blood flow with a fast and simple selfapplication which requires minimal training. Figure 3. Emergency & Military Tourniquet (EMT) Military Emergency Tourniquet (MET). The MET (Figure 4) was constructed with a constriction band, tourniquet base, and aluminum windlass. Figure 4. Military Emergency Tourniquet (MET) M2 Ratcheting Medical Tourniquet (Combat version; RMT-CBT) and (Tactical version; RMT-TAC). The RMT-CBT (Figure 5) and RMT-TAC (Figure 6) were designed to control lifethreatening extremity bleeding. These tourniquets are the only available self-locking tourniquet. The tourniquets are compact, lightweight, and rugged, and can be applied with one hand. The RMT-CBT is black in color, while the RMT-TAC is tan. The width of the ratchet strap on the RMT-TAC is slightly smaller than the RMT-CBT (McKeague, 2012). Page 9

11 Figure 5. M2 Ratcheting Medical Tourniquet (Combat) Figure 6. M2 Ratcheting Medical Tourniquet (Tactical) SWAT-Tourniquet (SWAT-T). The SWAT-T (Figure 7) was designed as a multipurpose dressing, with a unique Stretch, Wrap, and Tuck (SWAT) design for ease of use. It has been heat and cold tested and has an extended shelf life of up to five years. Figure 7. SWAT-Tourniquet Special Operations Forces Tactical Tourniquet Wide (SOFTT-W). The SOFTT-W (Figure 8) was designed with high-strength, lightweight alloy components, used in critical areas of function, to ensure reliability in challenging circumstances and on the largest limbs. The tourniquet has a 1-1/2" tourniquet strap and a quick-connect buckle eliminating the need to ever re-thread the strap, allowing for a faster, easier application. Page 10

12 Figure 8. SOFTT-W Tourniquet Test Procedures Experimental Setup. Both Phase IIa and Phase IIb consisted of four different experimental conditions. Condition I was the application of tourniquets in dry conditions during daylight, while Condition II was the application of tourniquets in dry conditions during darkness. The use of Night Vision Goggles (NVG) by the volunteers simulated darkness condition. Conditions III and IV repeated the day and darkness conditions, respectively, but the tourniquets were soaked in a simulated blood mixture for both (Simulated Blood - New Stain Resistant Formula, Vata Inc.) The four conditions were executed sequentially, and the order in which tourniquets were applied was randomized for each condition. Volunteers applied each type of tourniquet for a given test condition before moving on to the next. During both Phase IIa and Phase IIb, volunteers were asked to complete the tests at their own pace, and rest periods were given in between tourniquet applications. Volunteers were limited to no more than two tests per day. Volunteer Training. All volunteers were briefed on the manufacturers instructions for the proper application of each tourniquet. Following the brief, volunteers practiced applying each type of tourniquet according to its manufacturer s instructions. Research personnel then verified each volunteer s successful placement and application of each tourniquet and addressed any questions prior to beginning testing. Nine volunteers participated in both Phase IIa and Phase IIb. Those nine received refresher training and again demonstrated proper application of each tourniquet before beginning Phase IIb. Phase IIa - Mid-Thigh Application. Ten volunteers participated in Phase IIa, which tested a total of seven tourniquets (CAT, SOFTT-W, RMT-CBT, RMT-TAC, EMT, MET, and SWAT-T) under each of the four conditions. Once ready, the volunteer would begin by opening the tourniquet package and attempt to apply the tourniquet to the mid-thigh of the HapMed Page 11

13 Instrumented Leg for Tourniquet Testing. Volunteers were monitored throughout test periods, and test administrators recorded all events, including start and stop time, occlusion reached, occlusion maintained for one minute, and the pressure at which occlusion achieved. Phase IIb - Upper-Humerus Application. Eleven volunteers participated in Phase IIb, which tested the five tourniquets that met the success criteria in Phase IIa (CAT, SOFTT-W, RMT-CBT, RMT-TAC, and EMT). Tourniquets were tested under each of the four conditions, and volunteers applied the tourniquets to the upper-humerus of the HapMed Instrumented Arm for Tourniquet Testing. Again, volunteers were monitored throughout test periods, and test administrators recorded all events, including start and stop time, occlusion reached, occlusion maintained for one minute, and the pressure at which occlusion achieved. RESULTS & DISCUSSION Phase IIa - Success Rate. A total of ten volunteers participated in Phase IIa and completed testing of the seven tourniquets (CAT, SOFTT-W, RMT-CBT, RMT-TAC, EMT, MET, and SWAT-T) under the four experimental conditions (/, /Wet, Darkness/, and Darkness/Wet). Of the seven tourniquets evaluated, the CAT, SOFTT-W, RMT-CBT, RMT-TAC, and EMT achieved a >80% success rate, attaining occlusion within the allotted five minute time period, and maintaining occlusion for a one minute period throughout all four experimental conditions (Figure 9). Across the four conditions evaluated, there were no significant differences in the volunteers ability to apply the five successful tourniquets. Both the MET and the SWAT failed to achieve a >80% success rate in all four experimental conditions (Figure 9), and thus, were not eligible to move on to Phase IIb. Volunteers had difficulty maintaining MET strap tension while rotating the windlass. Additionally, there were difficulties in securing the windlass depending on the where the strap material collected as the windlass was tightened. Excess strap material collects in a spiral as the windlass turns, and depending on how the spiral forms, the windlass can be pushed toward or away from the securing strap. This made it difficult for some volunteers to secure the windlass after adequate tension was achieved. Page 12

14 % Testing Success Rate 100% 80% 60% 40% 20% 0% CAT SOFTT-W RMT-CBT RMT-TAC EMT MET SWAT Darkness Wet Darkness Wet Figure 9. Phase IIa, Tourniquet Test and Evaluation by Non-Medical Volunteers on the Hap-Med Instrumented Leg Trainer. Non-medical Volunteer subjects (n =10) were included in test and evaluation of the seven tourniquet devices under the four field-like conditions (/, /Wet, Darkness/, or Darkness/Wet) utilizing the Hap-Med Instrumented Leg Trainer. An effective tourniquet was one in which occlusion was reached within the 5 min test period and occlusion maintained for the 1 min occlusion period. A failed tourniquet included failure to reach or maintain occlusion, or any critical malfunction, deformation or breakage. The SWAT had a combination of breakages, including two critical failures where the device material ripped during application (Figure 10). Additionally, the SWAT had failures to reach and maintain occlusions. The physical requirement for application was difficult for several of the volunteers and made applying and securing the device unobtainable. Of the tourniquets that achieved success in Phase IIa, the CAT was the only tourniquet to experience a mechanical failure. The failure occurred when the windlass was tightened before adequate tension was applied to the main strap. This resulted in the D-ring and the windlass being forced together, causing damage to the tourniquet (Figure 11). Figure 10. SWAT Tourniquet Ripped During Application. Example of failure of the SWAT Tourniquet due to device being ripped during application. Page 13

15 Figure 11. Deformity of CAT leading to failed application. During application of the CAT, where volunteer failed to tighten the main strap securely before initiating the windlass process. Once windlass exceeds four 180º rotations the space between the D-Ring and the windlass assembly is removed and the continuation of additional windlass turns resulted in tourniquet damage and failure. Phase IIa - Application Time. The time required for application of each tourniquet device was measured and recorded. As shown in Figure 12, the CAT, SOFTT-W, RMT-CBT, RMT- TAC and EMT achieved proper application, on average, in (+22.96) seconds. The MET device required, on average, (+64.69) seconds to apply, while the SWAT device required, on average, (+82.14) seconds to apply. The MET and the SWAT were the most difficult for the volunteers to apply and tended to require multiple adjustments and reapplications to achieve occlusion. Throughout the MET tests, there were four instances in which a volunteer had to reapply the tourniquet, and throughout the SWAT tests, there were 16 instances in which the volunteer had to reapply the tourniquet to achieve occlusion. The multiple reapplications contributed to longer application times. Between the four test conditions, there were not significant differences in times to apply the tourniquets. The SWAT tended to take longer to successfully apply during the two wet conditions, although the effect was not found to be statistically significant. Page 14

16 Application Time (Seconds) Darkness Wet 0 CAT SOFTT-W RMT-CBT RMT-TAC EMT MET SWAT Figure 12. Application Times of Tourniquets to HapMed Instrumented Leg Trainer across Experimental Conditions. Non-medical Volunteer subjects (n =10) were included in test and evaluation of the seven tourniquet devices under the four field-like conditions (/, /Wet, Darkness/, or Darkness/Wet) utilizing the Hap-Med Instrumented Leg Trainer. Time to reach occlusion was reported and graphed. Average time for each field condition is represented, and error bars indicate standard deviations. A maximum time of 300 seconds was applied to those tourniquets that did not achieve occlusion within the test period. Phase IIa - Application Pressure. There were no significant differences in application pressures among the seven tourniquets tested; however, the wider EMT and SWAT tourniquets tended to require slightly less pressure to achieve occlusion on the HapMed Instrumented Leg (Figure 13). Application Pressure (mmhg) Darkness Wet 0.00 CAT SOFTT-W RMT-CBT RMT-TAC EMT MET SWAT Figure 13. Average Tourniquet Application Pressure Across the Four Experimental Conditions Tested. Nonmedical Volunteer subjects (n =10) were included in test and evaluation of the seven tourniquet devices under the four field-like conditions (/, /Wet, Darkness/, or Darkness/Wet) utilizing the Hap-Med Instrumented Leg Trainer. Average tourniquet pressure was measured and graphed. Error bars represent standard deviation. Page 15

17 Phase IIb - Success Rate. The five successful tourniquets from Phase IIa, CAT, SOFTT- W, RMT-CBT, RMT-TAC and EMT, advanced to Phase IIb testing on the HapMed Instrumented Arm for Tourniquet Testing. A total of eleven volunteer subjects tested each of the tourniquets under the four experimental conditions (/, /Wet, Darkness/, and Darkness/Wet). All five tourniquets completed the four test conditions with a success rate of > 90%, with no breakage or deformities reported (Figure 14). No differences were seen in tourniquet success rates across the four experimental conditions tested. % Testing Success Rate 100% 80% 60% 40% 20% 0% CAT SOFTT-W RMT-CBT RMT-TAC EMT Night Wet Darkness Wet Figure 14. Phase IIb, Tourniquet Test and Evaluation by Non-Medical Volunteers on the Hap-Med Instrumented Arm Trainer. Non-medical Volunteer subjects (n =11) were included in test and evaluation of the five tourniquet devices under the four field-like conditions (/, /Wet, Darkness/, or Darkness/Wet) utilizing the Hap-Med Instrumented Arm Trainer. An effective tourniquet was one in which occlusion was reached within the 5 min test period and occlusion maintained for the 1 min occlusion period. A failed tourniquet included failure to reach or maintain occlusion, or any critical malfunction, deformation or breakage. Phase IIb - Application Time. The time required to successfully apply each tourniquet device was measured and recorded. As shown in Figure 15, the application times for each tourniquet were well below the five minute benchmark, across each of the four test conditions. The average time for all tourniquets tested was 52.5 (+28.8) seconds. There were no significant differences in application times between the five tourniquets, although the SOFTT-W tended to take slightly longer to apply than the other five, which was indicative of difficulties securing the windlass to its locking ring. The excess strap material can push the SOFTT-W windlass toward or away from the locking ring as the windlass tightens, which made it challenging for some of the volunteers to secure. Page 16

18 Application Time (Seconds) Darkness Wet 0 CAT SOFTT-W RMT-CBT RMT-TAC EMT Figure 15. Application Times of Tourniquets to HapMed Instrumented Arm Trainer across Experimental Conditions. Non-medical Volunteer subjects (n =11) were included in test and evaluation of the five tourniquet devices under the four field-like conditions (/, /Wet, Darkness/, or Darkness/Wet) utilizing the Hap-Med Instrumented Arm Trainer. Application time to reach occlusion was reported and graphed. Average time for each field condition is represented, error bars indicate standard deviation. A maximum time of 300 seconds was applied to those tourniquets that did not achieve occlusion within the test period. Phase IIb - Application Pressures. There were no significant differences in application pressures among the five tourniquets tested; however, the wider EMT tended to require slightly less pressure to achieve occlusion on the HapMed Instrumented Arm (Figure 16). Application Pressure (mmhg) CAT SOFTT-W RMT-CBT RMT-TAC EMT Night Wet Darkness Wet Figure 16. Average Tourniquet Application Pressure Across the Four Experimental Conditions Tested. Nonmedical Volunteer subjects (n =11) were included in test and evaluation of the seven tourniquet devices under the four field-like conditions (/, /Wet, Darkness/, or Darkness/Wet) utilizing the Hap-Med Instrumented Arm Trainer. Average tourniquet pressure was measured and graphed. Error bars represent standard deviation. Page 17

19 CONCLUSIONS In Phase II, test and evaluation conducted at the hands of non-medical volunteer subjects revealed noted differences in tourniquet function and ease of use. Volunteer subjects successfully applied tourniquets and obtained occlusion within 5 minutes using the CAT, SOFTT-W, RMT-CBT, RMT-TAC, and EMT devices, with a success rates of >80% on both the HapMed Instrumented Leg and the HapMed Instrumented Arm, in all four simulated field conditions. The MET and SWAT devices both failed to achieve >80% success rates in all four experimental conditions due to both mechanical failures and the inability to achieve and maintain necessary occlusion pressure. These data generated on field tourniquets in a controlled, experimentally validated system will aid the sponsor in selection of devices aimed at controlling extremity hemorrhage on the battlefield. Page 18

20 REFERENCES Bellamy, R. (1984). The causes of death in conventional land warfare: implications for combat casualty care research. Military Medicine, 149, Hines, W., & Montgomery, D. (1980). Probability and statistics in engineering and management science. New York: Wiley. Kragh Jr., J., O Neill, M.., Walters, T., Dubick, M.., Baer, D., Wade, C. Blackbourne, L. (2011). The military emergency tourniquet program s lessons learned with devices and designs. Military Medicine, 176, Mabry, R.., Holcomb, J., & Baker, A. (2000). United States Army Rangers in Somalia: An analysis of combat casualties on an urban battlefield. Journal of Trauma, 49, McKeague, A., & Cox, D. (2012). Phase 1 of Joint Operational Evaluation of Field Tourniquets. (Report No ). Naval Medical Research Unit San Antonio, TX. Page 19

21 ABBREVIATIONS CAT Combat Application Tourniquet DoD Department of Defense EMT Emergency & Military Tourniquet FDA Food and Drug Administration HapMed Haptic Medicine IFAK Individual First Aid Kit JOEFT Joint Operational Evaluation of Field Tourniquets MARCORSYSCOM Marine Corps Systems Command MET Military Emergency Tourniquet NAMRU-SA Naval Medical Research Unit San Antonio NVG Night Vision Goggles RMT-CBT M2 Ratcheting Medical Tourniquet (Combat version) RMT-TAC M2 Ratcheting Medical Tourniquet (Tactical version) SOFTT-W Special Operations Forces Tactical Tourniquet Wide SWAT Stretch, Wrap, and Tuck SWAT-T SWAT-Tourniquet USAMMDA United States Army Medical Material Command Page 20

22 REPORT DOCUMENTATION PAGE The public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA , Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB Control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1. REPORT DATE (DD MM YY) REPORT TYPE Technical Report 4. TITLE Joint Operational Evaluation of Field Tourniquets (JOEFT) Phase II 6. AUTHORS Rene Alvarez, PhD, D. Duane Cox, Roy Dory, MS 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Naval Medical Research Unit San Antonio 3650 Chambers Pass, BHT-2, Bldg 3610 JBSA, Fort Sam Houston, TX SPONSORING/MONITORING AGENCY NAMES(S) AND ADDRESS(ES) Marine Corps Systems Command 2200 Lester Street Quantico, VA DATES COVERED (from to) FY12 FY14 5a. Contract Number: 5b. Grant Number: 5c. Program Element Number: 5d. Project Number: 5e. Task Number: 5f. Work Unit Number: G PERFORMING ORGANIZATION REPORT NUMBER Report No SPONSOR/MONITOR S ACRONYM(S) MARCORSYSCOM 11. SPONSOR/MONITOR S REPORT NUMBER(s) 12. DISTRIBUTION/AVAILABILITY STATEMENT Government only and contractors 13. SUPPLEMENTARY NOTES 14. ABSTRACT Extremity hemorrhage remains one of the most prevalent causes of death on the battlefield. Due to advances in technology and new tourniquet designs, the Department of Defense (DoD) has found it necessary to assess the effectiveness and suitability of emerging tourniquet devices for their ability to control extremity hemorrhage, withstand environmental conditions on the battlefield, and compare ease of use from training to actual battlefield applications. In the current study, seven tourniquets were evaluated in the hands of non-medical volunteer subjects. Volunteers utilized either the mid-thigh of the HapMed Instrumented Leg for Tourniquet Training or the upper humerus of the HapMed Instrumented Arm for Tourniquet Training under four simulated field conditions:, simulated blood soaked, Darkness, or Darkness simulated blood soaked. Phase II was divided into two sub phases: Phase IIa, evaluation of the seven tourniquets using the mid-thigh of the training instrument; and Phase IIb, evaluation of successful Phase IIa tourniquets using the upper humerus of the training instrument. Of the seven tourniquets in Phase IIa, five achieved >80% success throughout all four experimental conditions, achieving proper application in an average time of (+22.96). Of the five tourniquets evaluated in Phase IIb, all five tourniquets achieved >80% success throughout all four experimental conditions, achieving proper application in an average time of 52.5 (+28.8) seconds, with no observed breakages or deformities. Phase II revealed noted differences in tourniquet function and ease of use. These data generated on field tourniquets in a controlled, experimentally validated system will aid the sponsor in selection of devices aimed at controlling extremity hemorrhage on the battlefield. 15. SUBJECT TERMS extremity hemorrhage control, tourniquet, CAT, SOFTT-W, RMT-CBT, RMT-TAC, EMT, MET, SWAT-T 16. SECURITY CLASSIFICATION OF: 17. LIMITATION 18. NUMBER 18a. NAME OF RESPONSIBLE PERSON a. REPORT b. ABSTRACT c. THIS PAGE OF ABSTRACT OF PAGES Commanding Officer UNCL UNCL UNCL UNCL 22 18b. TELEPHONE NUMBER (INCLUDING AREA CODE) COMM/DSN: (DSN: 389) Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std. Z39-18