DTIC ADA614655: Technique of Axillary Use of a Combat Ready Clamp to Stop Junctional Bleeding

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by  Defense Technical Information Center

AmericanJournalofEmergencyMedicine31(2013)1274–1289
ContentslistsavailableatSciVerseScienceDirect
American Journal of Emergency Medicine
journal homepage: www.elsevier.com/locate/ajem
Correspondence
TechniqueofaxillaryuseofaCombatReadyClamptostop used on May 18, 2012. The right subclavian artery was cannulated
junctionalbleeding☆,☆☆ withpumptubing.Watersimulatedbloodflowat500mL/minat56
beats/min (Watson-Marlow pump model 603S issue 1; Bacon
Junctional body regions are too proximal for a regular limb
Technical Industries, Inc, Concord, MA). The axillary artery was
tourniquettofitandincludethegroinandaxillaryareas[1,2].Recently,
isolated in the axilla, transected, and clamped with a hemostat in
we described a technique of the use of the Combat Ready Clamp
betweeniterationsofClampuse.Thearterylumenbleedingwasseen
(CombatMedicalSystems,Fayetteville,NC)inprehospitalhemorrhage
before,during,andafterdeviceuse.
controlandacadavermodelusedinitsregulatoryapproval,butsuch
Users target the underlying axillary artery in the deltopectoral
uses were only in the groin [3-5]. Uncontrolled upper extremity groove (where soldiers nestle rifle butts when shooting) of the
hemorrhage in war is common, disabling, and lethal; recently, we
abductedarm(Fig.1).Thetargetpointis1cmdistal(caudal)tothe
counted 833 US military casualties hospitalized with a junctional
palpabletipofthecoracoid;thissoft,lowpointiswheretheCombat
woundcodedduringthecurrentwars.Ofthe151casualtieswithan
ReadyClamp'sdiskheadiscentered.
upperextremityinjuryamenabletoaCombatReadyClampinaxillary
The guidelines for using the Combat Ready Clamp are as
use,16.6%diedofwounds(25/151;Kraghetal,unpublisheddata).To
follows: [6]
show users how to apply a Combat Ready Clamp to stop axillary
bleeding,weillustrateitstechniqueofuse.Tohelpusersunderstand 1. Snap off the large, circular disk head to use the inner square
thedevice'sefficacy,wereportdatausedinitsregulatoryapplication. pressuredisk(Fig.2).
Totestefficacy,weusedWakeForestUniversityMedicalCenter's 2. Slidethebaseplateundercasualtytotargetthepressurepoint.
cadaverhemorrhagecontrolmodel;butinsteadofgroinbleeding,we 3. Slidethebaseplateinuntiltheverticalarmtouchescasualty'sside
modeledaxillarybleedinginaprotocolapprovedbytheWakeForest nearthetarget(Fig.3).
institutionalreviewboard[4].Afterthedonorbequeathedthebody 4. Putdiskheadoverthetargettobecompressedparallelto—but
underethicaloversightoftheSchoolofMedicine,amalecadaverwas noton—theclavicle(Fig.4).
used(age,75years;weight,150lb).Thebodywasrefrigerateduntil 5. Adjustthehorizontalarmlengthbyusingitslockingpin.
6. Adjusttheverticalarmbyusingthelockingpintopressthedisk
☆ Sourcesofsupport:ThisprojectwasfundedwithinternalUSArmyInstituteof headontothetargettoslowbleeding.
Surgical Research funds and the Defense Health Program (Proposal 201105: 7. TurntheT-handleclockwisetocompressthetargetuntilbleeding
Operationalsystemmanagementandpostmarketsurveillanceofhemorrhagecontrol stops(Fig.5).
devicesusedinmedicalcareofUSservicepersonsinthecurrentwar)andnotfromany
8. Snapthebuckleandremovetheslackfromthestrap.
ofthefollowingorganizations:NationalInstitutesofHealth,WellcomeTrust,Howard
HughesMedicalInstitute,orother.Theworkhasnotbeenpresentedyet,exceptlocally 9. Writetheapplicationtimeonthestraplabel.
inpart.Financialdisclosuresthatmightrelatetothisworkareasfollows:DrKraghisan 10. WhenmovingthecasualtyduringCombatReadyClampuse,be
employeeoftheUSgovernmentandreceivesinstitutionalsupportwhereheworks,the carefulnottodisplaceit.
USArmyInstituteofSurgicalResearch.Noninstitutionalsupportoccasionallycomes
fromothergovernmentalagenciessuchastheDefenseHealthProgramandtheUS
ArmyMedicalResearchandMaterielCommandforspecificprojectsorrelatedwork.He
hasofferedfreeadviceonscientificmattersatnocosttoOperativeExperience,M2Inc,
Tiger Surgical LLC, Tactical Medical Solutions LLC, Combat Medical Systems Inc,
Composite Resources Inc, Delfi Medical Innovations Inc, North American Rescue
Products LLC, H & H Associates Inc, Creative & Effective Technologies Inc, TEMS
SolutionsLLC,BlackhawkProductsGroup,Hemaclear,TacticalDevelopmentGroup,
CompressionWorksLLC,Tier-OneQualitySolutions,KforceGovernmentSolutions,CHI
Systems,TacticalEmergencyandMedicalSimulationsTraining(TeamsT),AthenaGTX,
PélagiqueLLC,HawaiiProductDevelopmentInc,RevMedxInc,SAMMedicalProducts,
SpeerOperationalTechnologies,andEntrotechInc.Hehasreceivedpayment(special
governmentemployee)foroccasionalworkfortheFoodandDrugAdministrationfor
deviceconsultation(510(k)panelist).In2007,hereceivedsomefundsforworkforthe
National Institutes of Health. He has received honoraria for trustee work for the
nonprofit Musculoskeletal Transplant Foundation. He has worked as a technical
representativetotheUSgovernment'scontractingofficerinagreementswithPhysical
Optics Corporation; Resodyn Corporation; InternationalHeartInstitute ofMontana
Foundation; Daemen College; Noble Biomaterials, Inc; Wake Forest Institute of
Regenerative Medicine; National Tissue Engineering Center; Pittsburgh Tissue
EngineeringInitiative;UniversityofTexasSouthwesternMedicalCenter;Arteriocyte,
Inc;andKellySpaceandTechnology,Inc.
☆☆ Disclaimer:Theopinionsorassertionscontainedhereinaretheprivateviewsof
the authors and are not to be construed as official or reflecting the views of the
Department of Defense or US government. The authors are employees of the US
government.Thisworkwaspreparedaspartoftheirofficialduties,andassuch,thereis
nocopyrighttobetransferred. Fig.1.Positionedcasualtyforhemorrhagecontrolattheaxilla.
0735-6757/$–seefrontmatter.PublishedbyElsevierInc.
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31 AUG 2013 N/A -
4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER
Technique of axillary use of a Combat Ready Clamp to stop junctional
5b. GRANT NUMBER
bleeding.
5c. PROGRAM ELEMENT NUMBER
6. AUTHOR(S) 5d. PROJECT NUMBER
Kragh Jr. J. F., Johnson J. E., Henkel C. K., Dubick M. A.,
5e. TASK NUMBER
5f. WORK UNIT NUMBER
7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION
United States Army Institute of Surgical Research, JBSA Fort Sam REPORT NUMBER
Houston, TX
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Correspondence/AmericanJournalofEmergencyMedicine31(2013)1274–1289 1275
Fig.2.Circulardiskheadsnappedoffitsinnersquarediskheadbeforeuse.
Fig.4.Placingthesquarediskheadatopthetarget,parallelto—butnoton—theclavicle.
11. Inlitterloading,rollthecasualtyontotheuninjuredside,placeon
thelitter,androllthecasualtyontothelitter.
12. TokeeptheCombatReadyClampinplace,transportthecasualty Limitations of the present report are numerous. The design of the
ontheuninjuredsideorpadandraisetheinjuredside. presentstudywaslimitedinitspurposetoprovideadequatedatafora
13. Reassessandadjustthecasualtyandclampasindicated. regulatoryapplication,andcadaverexperimentsarelimitedintheir
14. TheCombatReadyClampshouldberemovedonlyata surgical abilitytomimictraumacare.Cadavermuscletoneisnegligible,andif
carefacility. present, such as in casualties who are awake, increased tone may
interfere with hemorrhage control measures by disturbing the
Efficacy was100% (15/15)in thecadavermodelfor controlling compressive effect of devices like the Combat Ready Clamp. The
axillaryhemorrhage(Table).ThehandleoftheCombatReadyClamp nearby brachial plexus to the clamp's compression may risk nerve
wasturnedanaverageof5.1turnsbeforehemorrhagewascontrolled palsyincasualties,butdataareabsent.
(median5;mode,4;range,3-10).Thehandlewasturnedinremoval By describing and illustrating the technique of use, the present
an average of 4.5 turns before hemorrhage returned (median, 4; studymayhelpincreaseawarenessofhemorrhagecontrolmethods
mode, 4; range, 3-6). Efficacy was 100% whether the shoulder was forprehospitalprovidersandfirstresponders.
abductedandexternallyrotated(10/10)orabductedandinternally
rotated(5/5). Acknowledgments
ThemainfindingofthepresentstudywasthattheCombatReady
Clamphad100%efficacyinalaboratorymodelincontrollingaxillary The authors acknowledge the Joint Theater Trauma Registry for
hemorrhage. This finding indicated that the Combat Ready Clamp providing data for this study. Ralph Sweet, RN, aided in protocol
couldplausiblycontrolaxillaryhemorrhageincare. management,dataacquisition,andanalysis.OtiliaSánchezaidedin
Fig.3.Verticalarmadjustmentforsquarediskheadcontactatopthetarget. Fig.5.TurningtheT-handleclockwisetocompressthetargettostopbleeding.
1276 Correspondence/AmericanJournalofEmergencyMedicine31(2013)1274–1289
Table [5] Kragh Jr JF, Murphy C, Dubick MA, et al. New tourniquet device concepts for
CombatReadyClampdatainaxillaryuse battlefieldhemorrhagecontrol.USArmyMedDeptJ2011:38–48.
[6] Instructions for use. Package insert labeling of the Combat Ready Clamp.
Iteration Efficacy: Shoulderposition Handleturn Fayetteville,NC:CombatMedicalSystems;2010.
yes/no number
On Off
Laboratoryassessmentofout-of-hospitalinterventionstocontrol
1 Yes Abduction,externalrotation 4 4 ☆
junctionalbleedingfromthegroininamanikinmodel
2 Yes Abduction,externalrotation 4 4
3 Yes Abduction,externalrotation 4 4
4 Yes Abduction,externalrotation 5 4
5 Yes Abduction,externalrotation 5 6 TotheEditor,
6 Yes Abduction,externalrotation 6 5
7 Yes Abduction,externalrotation 6 5
Junctional body regions between the trunk and its appendages,
8 Yes Abduction,externalrotation 6 6
9 Yes Abduction,externalrotation 6 6 suchasthegroin,aretooproximalforaregularlimbtourniquettofit
10 Yes Abduction,externalrotation 10 4 [1,2].Notsince1993’sBlackHawkDownhasjunctionalhemorrhage
11 Yes Abduction,internalrotation 5 4 control become such a hot topic in military casualty care [1–7]. In
12 Yes Abduction,internalrotation 4 4 February 2013, the US military’s Task Force Medical Afghanistan
13 Yes Abduction,internalrotation 3 3
requestedafillofagapinjunctionalhemorrhagecontrolasanurgent
14 Yes Abduction,internalrotation 4 4
15 Yes Abduction,internalrotation 5 4 operationalneed,meaningthatjunctionalhemorrhagecontroldevices
shouldbeconsideredurgentlytofillagapinmedicalcareinwar.A
smallbutgrowingbodyofevidenceindicatesthathemorrhagecontrol
manuscript preparation. Chris Murphy, Jason Cauley, and Steve canbeattainedout-of-hospitalwithmechanicalcompression,using
Stutsman of Combat Medical Systems provided the Combat Ready suchinterventionsasmedicaldevices,onapressurepointproximalto
Clampdrawingsandinstructions. a bleeding wound [3–9]. To evaluate laboratory use of junctional
hemorrhagecontrolinterventions,wegathereddataonstoppinggroin
JohnF.KraghJr.COL(Ret),MD bleeding in a manikin modelto understandthe plausibility of such
USArmyInstituteofSurgicalResearch interventionsforfuturehumansubjectresearch.
FortSamHouston,TX Underanapprovedprotocol,wetestedefficacyofinterventionsina
UniformedServices manikindesignedtotrainmedicsinout-of-hospitalhemorrhagecontrol
F.EdwardHébertSchoolofMedicine (CombatReadyClamp[CRoC]TrainerManikin,OperativeExperience,
UniversityoftheHealthSciences Inc,NorthEast,MD).Wefilledthebloodreservoirwith4litersofwater;
Bethesda,MD we refilled the reservoir after 5 iterations or 1.5 liters of lost fluid,
E-mailaddress:[email protected] whichevercamefirst.Themanikinhadaright-groingunshotwound
throughtheproximalthighwherethecommonfemoralarteryflowwas
JamesE.JohnsonPhD controllablebyskincompressionoveritattheleveloftheinguinalfold.
CenterforAppliedLearning Therewas3cmbetweenthepressurepointwherecompressionwas
WakeForestSchoolofMedicine applied and the proximal extent of the wound. Interventions were
WakeForestUniversity timed,bloodlosswasmeasured,andefficacywasnoted.Efficacywas
Winston-Salem,NC operationallydefinedasvisuallystoppedflowintothewoundfromthe
E-mailaddress:[email protected] vessellumen.Pearlsandpitfallsofinterventionusewererecorded.
Interventionstocontrolhemorrhageincludedmedicaldeviceuse,
CraigK.HenkelPhD manual or digital compression, and improvised use of a rock-like
AnatomicalResourceClinicalTrainingCenter kettlebell(tosimulatearockusedincareonthebattlefieldinacase
CenterforAppliedLearning recorded in the Department of Defense Trauma Registry in 2012).
DepartmentofNeurobiologyandAnatomy Interventions included digital (finger) compression, manual com-
WakeForestHealthSciencesSchoolofMedicine pression(heelofthehand),kneecompression,compressionbya50-
Winston-Salem,NC lb kettlebell (Hampton Fitness Products, Ventura, CA), and medical
E-mailaddress:[email protected] device use (Combat Ready Clamp, CRoC, Combat Medical Systems,
Fayetteville, NC; SAM Junctional Tourniquet, SAM, SAM Medical
MichaelA.DubickPhD Products, Portland, OR; Junctional Emergency Treatment Tool, JETT,
DamageControlResuscitation North American Rescue Products, Greer, SC; Abdominal Aortic
USArmyInstituteofSurgicalResearch Tourniquet,AAT,CompressionWorks,Hoover,AL).
Houston,TX The first device assessed was the CRoC which, of the devices
E-mailaddress:[email protected] studied,wasclearedfirstbytheUSFoodandDrugAdministrationon
August11,2010.Thefirstsettingoftheevaluation(whichwasforthe
http://dx.doi.org/10.1016/j.ajem.2013.02.027 CRoC)wasinasimulationcenteraspreviouslyreportedwiththreeto
fivepeople,andtheothersettingoftheevaluationwasonatablewith
onetothreepeople[5].Thedatafromthatinitialsettingisincluded
References hereforcomparisonoftimetostopbleeding,bloodlossvolume,and
deviceefficacy[5].Sincethebloodlossratewasnon-linear(asitisin
[1] TaiNR,DicksonEJ.Militaryjunctionaltrauma.JRoyArmyMedCorps2009;155(4): realsituationsforcasualtiesbecausebleedingisbriskerinitiallyrather
285–92. than later), we did not refill the bladder after each iteration. The
[2] FickeJR,ObremskeyWT,GainesRJ,etal.Reprioritizationofresearchforcombat
casualtycare.JAmAcadOrthopSurg2012;20:S99-102.
[3] Tovmassian RV, Kragh Jr JF, Dubick MA, et al. Combat Ready Clamp medic ☆ Disclaimer:Theopinionsorassertionscontainedhereinaretheprivateviewsofthe
technique.JSpecOperMed2012;12(4):70–8. authorsandarenottobeconstruedasofficialorreflectingtheviewsoftheDepartment
[4] Kragh JF Jr, Murphy C, Steinbaugh J, et al.: Prehospital emergency inguinal ofDefenseorUSGovernment.TheauthorsareemployeesoftheUSGovernment.This
clamp controls hemorrhage in cadaver model. Mil Med MILMED-S-12.00568. workwaspreparedaspartoftheirofficialduties,andassuch,thereisnocopyrightto
Inpress. betransferred.