Page 31 - JSOM Winter 2019

FIGURE 1 Tourniquet, Nonpneumatic fielded circa 1960s–2004. term tourniquet. The vast majority were related to in-hospital
orthopedic and surgical tourniquets. About 150 articles were
relevant to battlefield or prehospital tourniquets with many
encouraging the use of tourniquets but not evaluating the de-
vices. Of these, there were approximately 60 articles focused
on the study or comparison of commercial tourniquet efficacy
or performance. However, many included devices that were
outdated or no longer in production. For example, articles
published prior to 2009 provided evidence on CAT genera-
tions 4 and 5 which are no longer produced and should be
out of the usable inventory. As such, the analysis of evidence
primarily focused on medical literature since 2012 in order
to assess data on the devices currently manufactured and
available.

When reviewing the evidence to assess the efficacy, efficiency,
and safety of tourniquets, it is incumbent upon the reader to
understand that there is a difference between laboratory con-
devices has not been clearly delineated through evidence-based ditions and battlefield conditions. For example, a tourniquet
research or science. Further, for the published evidence avail- may perform well when applied to the thigh while in a seated
able, there has been a wide variance as to the efficacy study position in a lab with two hands. However, the same tourni-
definitions, metrics and requirements. quet may be difficult to apply to a thigh at night in a Care
Under Fire situation. The data and evidence from laboratory
In 2004, the USAISR conducted tests of 10 limb tourniquet studies and actual use are considered in the tourniquet review.
designs based on requirements and specifications previously Tourniquets with both laboratory and use in combat has a
indicated by Calkins et al. and feedback from the field of stronger level of evidence.
5
ongoing combat operations. The CoTCCC reviewed the test
results and in 2005 identified the CAT, SOFT-T, and Emer- The reader also needs to consider factors that are known to
gency and Military Tourniquet (EMT) as the CoTCCC-rec- affect occlusion pressure and tourniquet efficacy. In a lab set-
ommended limb tourniquets for fielding to deploying forces. 1 ting, it can be difficult when using volunteers or trainers, to
accurately control for and evaluate factors that are known to
In subsequent years, the CoTCCC recommended tourniquets lead to loss of occlusion pressure such as application of a tour-
underwent several modifications based on continued feedback niquet to a contracted muscle, which subsequently relaxes;
from real casualty applications in Operation Enduring Free- extremity circumference; blood pressure; increased blood
dom (OEF) and Operation Iraqi Freedom (OIF). Additionally, pressure following resuscitation; or loss of extracellular fluid
other manufacturers developed alternative devices as both under the tourniquet. All of these factors are known to affect
an innovative improvement to hemorrhage control as well as the successful application of an arterial tourniquet. Thorough
market share competition. Some of these devices underwent understanding of the biomechanics of tourniquet use and fre-
research and scientific efficacy studies as part of DoD-funded quent reassessment is critical to successful use of a tourniquet.
research projects and as independent studies through other or-
ganizations. However, in the subsequent years, the CoTCCC Methodology
did not review and provide any additional recommendations
regarding the tourniquets on the market. The military ser- Over the years, tourniquet requirements and assessment cri-
vices generally have fielded tourniquets recommended by the teria has been published with most having similar criteria.
5,6
CoTCCC. Several studies conducted by the Naval Medical Research
Unit-San Antonio (NAMRU-SA) utilized the military tourni-
quet characteristics identified by the 2010 DoD Tourniquet
Discussion
Summit. Additionally, Dr John F Kragh Jr outlined limb tour-
7
The primary goal of this comprehensive tourniquet review is to niquet requirements and guidelines in multiple papers. In Sep-
6
(1) review the previously recommended tourniquets; (2) deter- tember of 2018, a breakout working group at the CoTCCC
mine if additional commercial tourniquets warrant CoTCCC meeting outlined the critical criteria that would be used to
recommendation; and (3) identify commercial tourniquets further evaluate the available evidence. This working group
that require further review or do not currently warrant rec- panel included several voting members of the CoTCCC, repre-
ommendation. The secondary goal is to establish a CoTCCC sentatives from AMEDDCandS-CDID, USUHS, DHA, and the
preferred features guideline for the research, development and Services. The working group prioritized the following assess-
testing of military limb tourniquets as well as the manufacture ment criteria going forward in this review and for CoTCCC
of battlefield limb tourniquets. The tertiary goal is to establish preferred features of military limb tourniquets.
a model for future reviews of CoTCCC recommended devices
and products on a recurring basis. FDA Approved – In order to be included, all devices must be
FDA approved as a tourniquet. At the time of writing, there
The process of reviewing commercial tourniquets was focused were 1,627 devices approved by the FDA as tourniquets.
on analysis of the evidence published in medical literature
and DoD reports. Between 2000 and 2018, there were over Scoring – For the purposes of this review, each component of
6,800 articles found on a PubMed search using the search tourniquet criteria was scored on a weighted scale of zero (0)

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