Page 42 - Journal of Special Operations Medicine - Fall 2016
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The thigh was laid on a laboratory benchtop and was   Results were  summarized  by outcome and by tourni-
            operated in accordance with the manufacturer’s instruc-  quet model. The critical, or primary, outcome was effec-
            tions. The thigh did not bleed, but bleeding was repre-  tiveness (yes-no, bleeding control). Another important
            sented by red lights that transilluminated the wound.   outcome was absence of palpable pulse distal to the
            The number of lights illuminated represented the bleed-  tourniquet (yes-no). Secondary outcomes included time
            ing rate: all 26 lights illuminated indicated uncontrolled   to stop bleeding (seconds); pressure (mmHg) applied to
            bleeding; few lights blinking indicated intermediate con-  the skin by the tourniquet to achieve hemorrhage con-
            trol; no lights illuminated indicated bleeding had stopped.   trol, and the calculated volume of simulated blood loss
            Arterial pulses were palpable in the popliteal area distal   (mL). Pump counts were the number of squeezes of the
            to the site of tourniquet application. Touchpad readouts   bulb by iteration. Effectiveness and pressure were mea-
            for each iteration included bleeding control, the time to   sured by the manikin, whereas pump counts and pulse
            stop bleeding, the total time of use, the pressure exerted   stoppage were determined by the user.
            under the tourniquet, and the simulated blood loss vol-
            ume. Total time was the sum of time to stop bleeding   Descriptive statistics were used to portray results. Cat-
            and the “after time”; after time was the additional time   egorical data (bleeding control and pulse stoppage
            taken for more pumps of the bulb and user assessment of   in 2-by-2 contingency tables) were analyzed with a
            the pulse by palpation and bleeding by inspection. The   chi-square test and the likelihood ratio  p values were
            measure of time to determination of bleeding control ex-  reported. For pairwise comparison of models, a non-
            tended from the start of the iteration until the manikin   parametric Wilcoxon method was used. For pairwise
            detected that no more blood was lost. Effectiveness was   comparison of model means, the Tukey method was
            determined by the cessation of blood loss (i.e., bleeding   used. Significance for results was established at p < .05.
            control [yes-no] at the time of determination).    All statistical analysis was conducted using SAS version
                                                               9.2 (SAS Institute, http://www.sas.com/) and MS Excel
            Iterations began with a tourniquet laid out flat and un-  2003 (Microsoft, https://www.microsoft.com). Parame-
            done on the benchtop. Iterations ended when the user   ters of reported data, such as differences between means,
            touched the touchpad button, assessing that the bleed-  were rounded to the decimal place as used routinely in
            ing was stopped. The user tightened tourniquets until he   either care or research.
            perceived that simulated bleeding stopped. The casualty
            had a medium build and the setting was Care Under Fire,   Results
            a setting resembling emergency care when under gunfire.
                                                               Each model had one device used for the entire experi-
            The manikin settings also included a constant simulated   ment, because no device needed to be replaced for any
            hemorrhage rate (635mL/min). The touchpad reported   reason such as breakage, wear, or tear. No safety issue
            simulated blood loss volume as calculated from arterial   occurred. Of note, the quality assurance information of
            flow and time. With such a rate, the resulting bleed-out   an imprint of manufacture date faded or wore off on the
            time was 4 minutes, and in the absence of any hemor-  TPT2 after use such that only the first two digits, 06,
            rhage control, simulated death would occur then. If par-  remained legible at the end of the experiment.
            tial hemorrhage control occurred, then longer survival
            would occur.                                       Neither tourniquet effectiveness (p = 1; likelihood ratio,
                                                               0) nor pulse cessation (p = 1; likelihood ratio, 0) differed
            Additional data were derived from results that were cal-  among tourniquet models: all three models had 100%
            culated from other data; one such example was bleeding   (30 of 30 tests) for both outcomes.
            rate (mL/s) as blood volume lost divided by the time to
            stop bleeding; and another example was after time, the   Differences in mean time to stop bleeding by model were
            total time minus the time to stop bleeding. Two compos-  statistically significant in one-way analysis as TPT2 (90
            ite outcomes were made of existing data from five pa-  seconds) was slower than the other models (64 seconds
            rameters: effectiveness, time to stop bleeding, pressure,   and 47 seconds for TPT3 and EMT, respectively; Fig-
            blood loss volume, and breakage. The first composite   ure 2). In pairwise comparison, the mean differences of
            was set as a binary outcome (good-bad) and was good   TPT2-TPT3 (25 seconds) and TPT2-EMT (42 seconds)
            only if all five parameters had a favorable outcome (yes   were statistically significant (p = .0027 and p < .0001,
            effectiveness, <61 seconds, application pressure between   respectively), but the mean difference of TPT3-EMT (17
            151 and 499mmHg  inclusive, blood loss  of <500mL,   seconds) was not (p = .055).
            and no breakage of the tourniquet). The second com-
            posite outcome was simply the count (0 to 5) of the five   Differences in mean total time by model were statisti-
            parameters  if  they  were  favorable.  Tourniquets,  itera-  cally significant in one-way analysis: TPT2 (110 sec-
            tions, and outcomes were uniquely identified.      onds) was slower than the other models (77 seconds and



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