Page 67 - Journal of Special Operations Medicine - Fall 2014

officers (NCOs) of the rank of staff sergeant (E-6; Mili- the groin), so the number of tests for a tester was eight
tary Occupational Specialty 68W, Healthcare Special- (four models × two sides); a tester applied the four tour-
ist); 100% had combat experience. niquets for a total of eight times to one casualty. This
testing resulted in a total of 72 tests (nine testers × four
Before working with human subjects, these medics were devices × two sides).
trained to proficiency by the assessors through the use
of (1) online videos, (2) user hardcopy instructions, (3) The focus of the testing was the medics’ experience
device handling, and (4) three consecutive, successful in tourniquet use. The surrogate for bleeding was the
uses of the device on a manikin (CRoC Trainer Manikin, presence of a distal pulse detected by using hand-held
Operative Experience, Inc.; http://operativeexperience Doppler transducer (Nicolet Vascular Elite Model 100;
.com/). Ten medics were trained to proficiency. One Viasys Healthcare, Conshohocken, PA), which makes an
medic withdrew from the testing because of a recurrence audible pulse sound. Pulse absence represented hemor-
of mild, temporary, and focal abdominal discomfort as- rhage control. Effectiveness was defined as stopping the
sociated with polycystic ovarian disease. The discomfort distal pulse by Doppler auscultation. The distal pulse
recurred in the first seconds of use of the first device ap- check was in the leg (Doppler flow detection) in the pos-
plied, so testing was not completed for this individual. terior tibialis artery at the ankle.
The nine remaining medics participating in the present
study (seven men and two women) tested the tourni- Safety was defined as an absence of adverse events (any
quets on one another; the participants alternated be- undesirable sign, symptom, or medical or psychological
tween being testers and simulated casualties. condition). Uncomplicated pain that resolved promptly
after device use was not considered an adverse event
At the time of the study, the US Food and Drug Ad- even if the subject stopped the test iteration due to pain.
ministration (FDA) had approved only four models of Safety issues were sought by observation during the test-
junctional tourniquet for inguinal hemorrhage control ing by the two assessors in real-time. The subjects were
(Table 1) in the United States. These tourniquets were assessed throughout the duration of testing, which took
the CRoC, AAJT, JETT, and SJT. Because the inguinal 3 hours of the subject’s time.
area was the only indicated body area that all four tour-
niquets shared, it was used as the testing site. The right Tourniquets were placed near the user open and ready for
groin was assessed first; the left groin was assessed sec- use; the tourniquets were neither packaged nor packed
ond. Unilateral groin hemorrhage was simulated. away. In testing, the tourniquets were put on or near the
groin in accordance with the instructions for use of each
Each tester used each of the four models of tourniquet model. The AAJT was applied to the umbilicus; other
two times (once on the left and once on the right side of models were applied to the groin. The order of testing

Table 1 Junctional Tourniquet Traits for Models That Are Currently US FDA Cleared

Name of Abdominal Aortic and Junctional Emergency SAM Junctional
Tourniquet Model Combat Ready Clamp Junctional Tourniquet Treatment Tool Tourniquet
Short name CRoC AAJT JETT SJT
North American Rescue
Maker Combat Medical Systems Compression Works SAM Medical Products
Products
City, state Fayetteville, NC Hoover, AL Greer, SC Wilsonville, OR
510(k) date(s) 8/11/10; 4/29/13 10/18/11; 12/6/2013 1/3/13 3/18/13, 7/24/13
FDA number(s) K102025; K130482 K112384, K133029 K123194 K123694; K131561
NSN 6515-01-589-9135 6515-01-616-4999 6515-01-616-5841 6515-01-618-7475
Cost 654 515 220 292.50
($USD, est. USG)
Weight (g) 799 485 651 499
Cube (L) 0.8 1.4 1.6 1.5
Battlefield, difficult Difficult inguinal or
Battlefield, difficult
Indication(s) inguinal, pelvis, or Difficult inguinal bleeds axilla bleeds, or pelvic
inguinal or axilla bleeds
axilla bleeds fracture immobilization
Source: FDA, US Food and Drug Administration; NSN, National Stock Number; USD, US dollars; USG, US government; 510(k) is the FDA
clearance.

Junctional Tourniquets to Control Simulated Groin Hemorrhage 59