Ultrasound Localization of Resuscitative Endovascular Balloon Occlusion of the Aorta in a Human Cadaver Model.

OBJECTIVE: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a method of gaining proximal control of noncompressible torso hemorrhage (NCTH). Catheter placement is traditionally confirmed with fluoroscopy, but few studies have evaluated whether ultrasound (US) can be used. METHODS: Using a pressurized human cadaver model, a certified REBOA placer was shown one of four randomized cards that instructed them to place the REBOA either correctly or incorrectly in Zone 1 (the distal thoracic aorta extending from the celiac artery to the left subclavian artery) or Zone 3 (in the distal abdominal aorta, from the aortic bifurcation to the lowest renal artery). Once the REBOA was placed, 10 US-trained locators were asked to confirm balloon placement via US. The participants were given 3 minutes to determine whether the catheter had been correctly placed, repeating this 20 times on two cadavers. RESULTS: Overall, US exhibited an average sensitivity of 83%, specificity of 76%, and accuracy of 80%. For Zone 1, US showed a sensitivity of 78% and specificity of 83%, and for Zone 3, a sensitivity of 88% and specificity of 76%. In addition, US exhibited a likelihood positive ratio (LR+) of 3.73 and a likelihood negative ratio (LR-) of 0.22 for either position, with similar numbers for Zone 1 (+4.57, -0.26) and Zone 3 (+3.16, -0.16). CONCLUSION: Ultrasound could prove to be a useful tool for confirming placement of a REBOA catheter, especially in austere environments.

iTClamp-Mediated Wound Closure Speeds Control of Arterial Hemorrhage With or Without Additional Hemostatic Agents.

BACKGROUND: Exsanguination is the leading cause of preventable posttraumatic death, especially in the prehospital arena. Traditional hemorrhage control methods involve packing the wound with hemostatic agents, providing manual pressure, and then applying a pressure dressing to stabilize the treatment. This is a lengthy process that frequently destabilizes upon patient transport. Conversely, the iTClamp, a compact wound closure device, is designed to rapidly seal wound edges mechanically, expediting clot formation at the site of injury. OBJECTIVES: To determine the efficacy of the iTClamp with and without wound packing in the control of a lethal junction hemorrhage. METHODS: Given the limited available information regarding the efficacy of the iTClamp in conjunction with traditional hemostatic agents, this study used a swine model of severe junctional hemorrhage. The goal was to compare a multiagent strategy using the iTClamp in conjunction with XSTAT to the traditional method of Combat Gauze packing with pressure dressing application. Readouts include application time, blood loss, and rebleed occurrence. RESULTS: Mean application times of the iTClamp treatment alone or in conjunction with other hemostatic agents were at least 75% faster than the application time of Combat Gauze with pressure dressing. Percent blood loss was not significantly different between groups but trended the highest for Combat Gauze treated swine, followed by iTClamp plus XSTAT, iTClamp alone and finally iTClamp plus Combat Gauze. CONCLUSION: The results from this study demonstrate that the iTClamp can be effectively utilized in conjunction with hemostatic packing to control junctional hemorrhages.

Speed, Skill Retention, and End User Perceptions of iTClamp Application by Navy Corpsmen on a Manikin Model of Femoral Hemorrhage.

INTRODUCTION: Tactical Combat Casualty Care guidelines recommend packing junctional wounds with gauze, applying direct pressure for 3 minutes, and then securing with an external pressure dressing. This method is time-consuming, which can be problematic in a combat environment. Alternatively, the iTClamp has documented efficacy and rapid application. However, no studies have evaluated device application by military prehospital medical providers, such as Navy corpsmen, or their user experience with the device. MATERIALS AND METHODS: Research data derived from a protocol were approved by the Naval Medical Center Portsmouth's Institutional Review Board in compliance with all applicable federal regulations governing the protection of human subjects. Navy corpsmen with the current Tactical Combat Casualty Care certification applied the iTClamp or standard pressure dressing on a manikin model of femoral hemorrhage in a crossover study design. Each participant used both devices in a randomized fashion. Time to application was recorded, and participants completed Likert scale surveys to evaluate both devices for preference, ease of use, and physical assessment. A repeat assessment was performed 1 month later to assess skill atrophy. Repeated-measures ANOVA was used to compare application time. Likert scale survey data were analyzed using Mann-Whitney and Wilcoxon tests to compare survey data within and between time points, respectively. RESULTS: The application of the iTClamp was more than twice as fast as the application of pressure dressings at both the initial and follow-up evaluations. There was no statistically significant difference in application times between the first evaluation and the 30-day assessment of either device, indicating no atrophy in skill. While 65% and 52% of the participants expressed preference in for the iTClamp in their surveys during the initial and follow-up respective visits, the difference in preference was not statistically significant for either the initial or the follow-up survey. Open-ended survey responses yielded both perceived advantages and disadvantages for each treatment option. CONCLUSIONS: In austere or hostile environments, speed of treatment and extrication can have significant implications for the safety of both the patient and the medical providers. Hemorrhage control interventions must be both effective and easy to use for a prehospital provider to ensure its efficacy in a live battlefield situation. The iTClamp is small, simple, and fast to use, but its wide adoption in the field may be based on limitations perceived by participants, including narrow indications for use. However, based on our findings, it is reasonable to field the iTClamp depending on provider preference.

A comparison of efficacy, efficiency, and durability in novel tourniquet designs.

BACKGROUND: Exsanguination due to extremity hemorrhage is a major cause of preventable traumatic deaths. Extremity tourniquet use has been shown to be safe and improve survival. The purpose of this study was to compare the efficacy, efficiency, and durability of the Generation 7 Combat Application Tourniquet (CAT; North American Rescue, Greer, SC), the Tactical Mechanical Tourniquet (TMT; Combat Medical Systems, Harrisburg, NC), and the SOF Tactical Tourniquet-Wide (SOFTT-W; Tactical Medical Solutions, Anderson, SC). METHODS: This study was a three-phase randomized, cross-over trial. In successive trials, subjects were timed during the application of each tourniquet to the upper and lower extremity. Following successful lower extremity application, subjects low crawled 25 ft and then were dragged 25 ft, after which effectiveness was reassessed, as defined by the cessation of distal pulses by Doppler ultrasound. RESULTS: In arm application, both the CAT and TMT had significantly less failure rates than the SOFTT-W (5.56%, 19.44%, 58.33%), with the CAT being the fastest tourniquet when compared with TMT and SOFTT-W (37.8 seconds, 65.01 seconds, 63.07 seconds). In leg application, the CAT had significantly less rates of failure when compared with the SOFTT-W, but there was no other significant difference between the tourniquets (27.78%, 44.44%, 61.11%). In addition, the CAT was significantly faster than both the TMT and SOFTT-W when applied to the leg (8.33 seconds, 40.96 seconds, 34.5 seconds). There was no significant difference in tourniquet failure rates between the three tourniquets after subject maneuvers in phase 3 (34.29%, 42.86%, 45.45%). DISCUSSION: The CAT is as effective as the TMT and significantly more effective than the SOFTT-W. In addition, the CAT demonstrated shorter application times than either the TMT or SOFTT-W. However, there was no significant difference between the three tourniquets in their ability to maintain pulselessness after subject maneuvers. LEVEL OF EVIDENCE: Care management, level II.