Page 52 - JSOM Fall 2022
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for comparison of hemorrhage control performance between   power) and “elevated” (471 ± 8mmHg; 100% pump power)
          the two tourniquet designs.                        systolic pressures (mean ± standard deviation). A summary of
                                                             the perfusion system details used in this study is provided in
                                                             Table 2.
          Methods
          Study Setting                                      Study Design
          Study protocol approval was granted under a previously ap­  Each tourniquet type was applied mid­thigh to a perfused ca­
          proved proposal submitted to the Wake Forest School of Med­  daver limb and evaluated in single, alternating order until 20
          icine Institutional Review Board. This human tissue study was   trials had been conducted for each under “normal” perfusion
          conducted at the Bowman Gray Center for Medical Educa­  parameters. The process was then repeated under “elevated”
          tion under the ethical oversight of the Wake Forest School of   perfusion parameters for an additional four alternating trials
          Medicine.                                          of each tourniquet type resulting in a combined total of 48 tri­
                                                             als. Trials were conducted on right side and left side anatomi­
          Perfused Cadaver Model                             cal sites at similar frequencies. Arterial occlusion was defined
          A standard, perfused human cadaver model was used in this   as the cessation of arterial fluid flow as determined by Dop­
          study to simulate life­threatening, arterial limb hemorrhage in   pler ultrasound auscultation. 13,21  Occlusion time was defined
          the research laboratory. 25–27  The cadavers were never frozen,   as the time elapsed from the start of tourniquet application
          not embalmed, and were preserved in refrigerated storage.   until arterial occlusion was achieved. 27,30  Application time was
          Four hours prior to study initiation, the cadavers were trans­  defined as the occlusion time plus the subsequent time elapsed
          ferred into the laboratory theater to gradually warm to ambient   during the final tourniquet securement steps until hands­free,
          temperature.  The cadavers were each placed on a dissection   completed application was achieved. 13,27,30  Success for a given
                    21
          table in a supine position, perfusion tubing was inserted and   trial was defined as the achievement of both cessation of arte­
          sewn into the abdominal aorta, and the lower extremities   rial flow and the completion of tourniquet application in < 4
                                                                    27
          were subsequently prepared for independent, regional arte­  minutes.  Ease of use and applied tourniquet pressure were re­
          rial perfusion of each leg using the Minneti method.  A deep,   corded at the time of application completion for each trial. 30,31
                                                  25
          5–8­cm­long incision was made on the lower, posterior side of
          each thigh severing the femoral artery. Vascular clamps were   Tourniquet Users
          used to restrict simulated hemorrhage to a single limb for each   A total of three persons applied the tourniquets individually.
          trial. The mid­thigh anatomical site was selected for tourni­  The study participants were, in order, a civilian­vascular sur­
          quet placement due to the expectation that it would generally   geon, a retired Navy SEAL, and a civilian­scientist. The tour­
          require higher arterial occlusion pressures than a calf, bicep,   niquet users were males between the ages of 35 and 60. None
          or forearm site based on the combined findings of Graham et   of the users had any previous training or experience applying
          al. and Gordon et al. 28,29  Each tourniquet was applied at the   the ST. The retired Navy SEAL had previous training and field
          same, prespecified mid­thigh location for a given limb to allow   experience applying the CAT, while the other participants had
          for consistent data collection, and the mid­thigh application   no previous training or experience applying the CAT. One day
          sites ranged between 33.0 and 35.5 cm in circumference. A   prior to the laboratory portion of the study, participants were
          summary of cadaver demographics is provided in Table 1.  issued two units of each tourniquet along with a copy of the
                                                             application instructions from the manufacturer of each. Ap­
          A  centrifugal  pump  and  solenoid  valve  were  serially  con­  plication instructions for the CAT are available at the manu­
          nected  and  digitally  controlled  to  produce  a pulsed  flow  of   facturer’s website, and the application instructions provided
          blood analog solution which simulated circulatory function in   on the ST product packaging are presented in Figure 1. Par­
          a hemorrhaging patient. 21,25,26  During the course of this study,   ticipants were instructed to self­train on the application of
          the perfusion pump system was operated at two different set­  each tourniquet prior to arrival at the laboratory the next day.
          tings to simulate both “normal” (146 ± 29mmHg; 40% pump   Throughout the laboratory portion of the study, all tourniquets


          TABLE 1  Cadaver Demographics
                                                                                                Mid-Thigh
                        Sex (M/F)   Ethnicity   Age, y*  Height, cm*  Weight, kg*  BMI*      Circumference, cm
           Cadaver 1       M          W          70         176         64         20.7      33.9 (R), 33.0 (L)
           Cadaver 2       M          W          65         183         70         20.9      35.5 (R), 35.3 (L)
           Mean                                  67.5       179.5       67         20.8           34.4
          BMI = body mass index, F = female, L = left thigh, M = male; R = right thigh, W = white.
          *Values are approximate.
          TABLE 2  Perfusion System Details
                             Peak Pulsate
                            Pressure, mmHg
                              Mean ± SE      Perfusion    Pulsed Flow   Flow Rate,   Blood Analog   Blood Analog
           Perfusion Pressure  (Med, Min, Max)  Pump Power  Interval, bpm  mL/min  Density, g/mL  Composition
                               146 ± 5
           “Normal”                           40%           80          63
                            (143, 115, 279)                                                  Water, Red Food Dye,
                                                                                    1.33
                               471 ± 3                                                       Confectioners’ Sugar
           “Elevated”                         100%          80          195
                            (469, 463, 484)
          bpm = beats per minute, max = maximum, med = median, min = minimum, SE = standard error.
          50  |  JSOM   Volume 22, Edition 3 / Fall 2022
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