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Tactical Mechanical Tourniquet                     formally applied for and granted (712/MODREC/15). Trials
          The TMT (Alphapointe , www.alphapointe.org) has been de­  took place between May and July 2016.
                            ™
          veloped in a similar manner to the C­A­T. Important differ­
          ences include a wider strap, a larger back plate, a “snap in”   Pilot
          self­application buckle, and a greater travel in the inner linear   In a pilot phase trial, feasibility, equipment, simulated hem­
          band between buckles. The manufacturer hypothesizes these   orrhage model, tolerance, and methodology were to be tested
          features potentially improve both ease of use and ability to   and validated. Three healthy British military volunteers were
          occlude the popliteal artery when compared with the C­A­T. A   enrolled. The data from this pilot trial are included in the to­
          single tourniquet that could be used at the mid thigh without   tals presented in Results.
          the need for a second (in side­by­side mode) would represent a
          logistical and tactical improvement.               Volunteers
                                                             The population of interest were currently serving British mil­
          The TMT  has been shown to be  effective when applied  to   itary personnel in a deployable role. Twenty­four healthy,
          a manikin thigh.  Another study determined the TMT to be   actively serving British military personnel were recruited to
                       7
          100% effective at occluding the popliteal artery within an ac­  participate (inclusive of three pilot volunteers). Inclusion
          ceptable pain threshold in healthy volunteers when applied by   criteria were actively serving British soldiers (any rank),
          a researcher.  Figure 2 shows the tactical mechanical tourni­  two intact lower limbs, and volunteering to participate. Ex­
                    8
          quet applied to the mid thigh. Table 1 illustrates the specifica­  clusion criteria were participation in a previous tourniquet
          tions of the TMT and the C­A­T.                    study, medically unfit to deploy in role, and vascular disease
                                                             or previous surgery that would preclude tourniquet applica­
                                                             tion. Volunteers were recruited from 202 Field Hospital. No
                                                             volunteers had previously self­applied a C­A­T except during
                                                             training.

                                                             Methodology
                                                             The C­A­T and the TMT were tested by all subjects sequen­
                                   FIGURE 2  Tactical Mechanical   tially, one tourniquet on each lower limb at a time. Thus, the
                                   Tourniquet applied at the mid   number of replicates (tests) was 48: 48 limbs, 24 users.
                                   thigh but not fully tightened.
                                                             The order of tourniquet models and the order of the limb lat­
                                                             erality in which tourniquets were applied were randomized
                                                             per a previously detailed technique.  A prerandomized algo­
                                                                                         8
                                                             rithm was used to determine order for the whole cohort before
                                                             testing began.

          TABLE 1  Specifications of Tactical Mechanical Tourniquet (TMT)   Participants received a scripted brief on the correct application
          and Combat Applied Tourniquet (C-A-T)              of the models based on the instructions for use. Briefing oc­
                Specification       TMT          C-A-T       curred regardless of whether the volunteers had had previous
           Width of strap that encircles   50      40        training.
           limb, mm
           Width of strap that passes                        Simulated Hemorrhage
           through the windlass, mm  25            25        A model of simulated hemorrhage was used to aid subjects
           Length of strap that passes        Runs throughout   in determining how tightly to apply to the windlass to their
           through the windlass, mm  90       the length of the   lower limb. Portable ultrasound machines were used to moni­
                                                wider strap  tor popliteal artery flow. Ultrasound machines were a portable
           Base plate width, mm      58            38        SonoSite  (FUJIFILM SonoSite Inc, www.sonosite.com/) ma­
                                                                    ®
           Base plate length, mm     92            90        chine with a 10Mhz probe, and a portable GE Logiq­e (GE
           Windlass diameter, mm     10            10        Healthcare,  http://www3.gehealthcare.com/) machine with a
           Securing mechanism    Asymmetrical  Symmetrical   12mHz probe, each operated by a single consultant radiol­
           Windlass turn direction  Clockwise or   Clockwise or   ogist. The ultrasound Doppler waveform was visible to the
                                counterclockwise counterclockwise  study subject, and its appearance (including sound) during ces­
                                                             sation of arterial flow explained.
          Aim
          The C­A­T has been designed to be self­applied as well as ap­  The aim was for the participants to understand the point at
          plied by a third person. The aim of this study was to compare   which arterial occlusion occurred. The ultrasound operator
          self­application performance of the C­A­T with that of the   aided subjects in interpretation of results by offering verbal
          TMT in a simulated model of lower limb hemorrhage among   cues. These cues helped determine the point when Doppler
          healthy British military volunteers.               waveform evidenced absence of flow, and included phrases
                                                             such as “you’re still bleeding” and “bleeding has stopped.”
                                                             The subject was asked to self­apply each tourniquet sequen­
          Methods
                                                             tially to separate limbs at the mid­thigh level (defined as the
          Design                                             midpoint between the superior pole of the patella and greater
          A pilot study was performed before recruiting 24 healthy vol­  trochanter) to bare skin. Subjects were able to stop tourniquet
          unteers. Ministry of Defence Research ethical application was   use at any time, such as if pain was intolerable. After release of


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