1/8/2017 Arandomizedcontrolstudycomparingthepharyngolaryngealmorbidityoflaryngealmaskairwayversusendotrachealtube

AnesthEssaysRes.2016MayAug10(2):189194. PMCID:PMC4864682
doi:10.4103/02591162.174466

Arandomizedcontrolstudycomparingthepharyngolaryngealmorbidityof
laryngealmaskairwayversusendotrachealtube
A.Venugopal,RonMathewJacob,andRachelCherianKoshy
DepartmentofAnaesthesiology,RegionalCancerCentre,Thiruvananthapuram,Kerala,India
Correspondingauthor:Dr.A.Venugopal,DepartmentofAnaesthesiology,RegionalCancerCentre,Thiruvananthapuram695011,Kerala,India.E
mail:venuanila@yahoo.com

Copyright:Anesthesia:EssaysandResearches

ThisisanopenaccessarticledistributedunderthetermsoftheCreativeCommonsAttributionNonCommercialShareAlike3.0License,whichallows
otherstoremix,tweak,andbuildupontheworknoncommercially,aslongastheauthoriscreditedandthenewcreationsarelicensedundertheidentical
terms.

Abstract Goto:

Introduction:
Endotrachealtube(ETT)hasbeenassociatedwithvariouspharyngolaryngealmorbidities(PLMs)following
generalanesthesia(GA).Laryngealmaskairway(LMA),currentlythemostcommonlyusedsupraglotticairway
device,hasseveraladvantageousovertheETTbuthasbeenassociatedwithvaryingresultsofPLM.Theaimof
ourstudywastocomparethePLMbetweenthemandtoknowwhetherLMAisabetteralternative.

MaterialsandMethods:
OnehundredandseventyAmericanSocietyofAnesthesiologistsGrades1and2womenscheduledforelective
mastectomywereincludedinthestudy,85eachineithergroup,EGroup(intubatedwithETT)andLGroup(using
LMA)onarandombasis.AllpatientsreceivedGAwithcontrolledventilationusingamusclerelaxant.PLMssuch
ashoarseness,painonphonation,sorethroat,anddifficultyinswallowingweredocumentedbyaninterviewdone
postoperatively.Peroperativeparameterssuchasintubationattempts,traumaduringairwaydeviceinsertion,and
intraoperativeincidentswerealsoanalyzed.Asamplesizeof85patientsineachgroupwascalculatedinorderto
achieveastudypowerof0.8andalphalevelwastakenas0.05.DatawereanalyzedusingSPSSversion16using
Chisquaretest,MannWhitneyUtestandFisher'sexacttestwereusedasnonparametrictests.AtwotailedP<
0.05wasconsideredsignificant.

Results:
PatientsinEGrouphadstatisticallysignificantincreasedincidenceofasorethroatandvoicecomplaintswhereasL
Groupshowedastatisticallysignificantincreaseofswallowingproblems.Therewasalsoasignificantcorrelation
betweentraumaticinsertionandsorethroat,painonswallowingintheLGroup,whichcouldbeduetodirect
trauma.

Conclusions:
ETTwasassociatedwithanincreasedincidenceofvoiceproblemsandsorethroatwhereasLMAhadanincreased
incidenceofdysphagiaandodynophagia.UseofLMAchangesthepharyngolaryngealprofiletoamoreacceptable
one.

Keywords:Anesthesiageneral,endotracheal,intubation,laryngealmaskairway,morbidity,postoperativeperiod

INTRODUCTION Goto:

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1/8/2017 Arandomizedcontrolstudycomparingthepharyngolaryngealmorbidityoflaryngealmaskairwayversusendotrachealtube

Injuriestotheairwayarewellrecognizedcomplicationsofgeneralanesthesia(GA).Claimstoairwayinjuriesare
frequentinAmericanSocietyofAnaesthesiologists(ASA)closedclaimsdatabaseinwhichinjuriestothelarynx
representabout33%,mostofthemrelatingtolonglastingpainorvoicecomplaintsduetonerveapraxiaand
cartilagetrauma.[1]Sorethroathadbeenratedastheeighthmostadverseeffectinthepostoperativeperiod
followingGAwhichcancontributetopostoperativemorbidityandpatientdissatisfaction.[2]

Severalriskfactorsforpostoperativesorethroatduetoanendotrachealtube(ETT)havebeenidentifiedwhich
includefemalegender,age,surgicalsite,useofnitrousoxide,anddurationofsurgery.[3]Laryngealmaskairway
(LMA),themostpopularsupraglotticairwaydevice,issaidtohavealowerincidenceofpostoperativesorethroat
andvoiceproblemsthoughwidevariationsintheirincidencearereported.[4]Inpediatricagegroup,theincidence
ofasorethroatbetweenendotrachealintubationandLMAarenotsignificant.[5]Inthisstudy,wecomparedthe
wholespectrumofpharyngolaryngealmorbidity(PLM)suchashoarseness,painonphonation,dysphagia,
odynophagia,andsorethroatbetweentheLMAandETTafterprovidingadequateanestheticdepthatthetimeof
intubation,avoidingnitrousoxide,anddurationofsurgeryrestrictingto2hwhicharesignificantpredictorsof
postoperativesorethroat.[3]Inaddition,wecomparedtheincidenceofvariousperioperativeeventsandtheir
significanceonPLM.

MATERIALSANDMETHODS Goto:

AfterobtainingapprovalfromtheInstitutionalReviewBoardandEthicsCommitteearandomizedcohorttrial
involving170patientsundergoingelectivemastectomywereallocatedtoeitherGroupE(intubatedwithETT)or
GroupL(LMAclassicastheairwaydevice)usingacomputergeneratedrandomtable.

Afterawritteninformedconsent,170womenofASAstatus1and2intheagegroup1860yearsscheduledfor
electivemastectomylasting12hwereincludedinourstudy.Exclusioncriteriaweredifficultairwaywith
Mallampatti(MP)Class3and4,historyofnausea,vomiting,orasorethroatwithin24hofsurgery,obesity,and
gastroesophagealreflux.Thosewithpreoperativevoiceandswallowingproblemsandrequiringmorethanthree
attemptsforairwaydeviceplacementwerealsoexcluded.

Allpatientswerepremedicatedorallywithalprazolam0.5mgonthenightbeforeandabout2hbeforeinduction.
Inthepremedicationroombaselineparameterssuchasheartrate,bloodpressure,electrocardiogram,andoxygen
saturationwererecorded,intravenous(I/V)fluidstartedandmidazolam1mg,fentanyl2g/kgweregivenbefore
induction.Afterpreoxygenation,I/Vlidocaine1.5mg/kgwasgivenandanesthesiainducedwithpropofol2.0
mg/kgandmusclerelaxationobtainedwith0.1mg/kgvecuronium.Patientswereventilatedwith35%oxygeninair
andisofluranedialconcentrationadjustedtoachieveaminimumalveolarconcentrationof1aspertheavailablegas
monitoringtoensureadequatedepththroughouttheprocedure.Tracheaintubatedwithappropriatesizedcuffedoral
ETTandconfirmedwithendtidalcarbondioxideandauscultationforbilateralairentry.Cuffwasinflatedjustto
preventairleakandtubewassecured.LMAinsertioninvolvedpreparationofthedevice(cuffdeflatedandwell
lubricatedwithKYjelly)andblinddigitalinsertionperformedandpositionconfirmedasabove.Cuffwasinflated
aspertheinstructionsofthemanufacturerandthedevicesecured.Amaximumofthreeattemptstopositionthe
devicewereallowed,beforeproceedingtoalternatemethodofairwaymanagementandsuchcaseswererecorded
andexcludedfromthestudy.Anesthesiawasmaintainedwithairoxygenmixturewithinspiredoxygenof35%.A
perioperativedataformcontainingintubationdataandperioperativeincidentswerealsofilledwhichdocumentsthe
numberofattemptsoranytraumatooropharynxduringintubation/LMAinsertion.Morethanoneattemptwas
takenasaperioperativeincident.Anyintraoperativeuntowardincidentsuchasabnormalriseinairwaypressure,
bucking,comingoutofanesthesiaduringtheprocedure,andextubationtimeeventswerealsonoted.

Thetraumatic/atraumaticcriteriawasbasedonwhethertherewasanybloodontheETT/LMAatthetimeof
extubationand/oranyvisibledamagetotheoropharynxafterextubationwhichincludestraumatothelips,teeth,or
gumincaseofendotrachealintubation.I/Vdiclofenacsodium/tramadolweregivenforpostoperativepainrelief.At
theendofthesurgeryneuromuscularblockadewasreversed,patientawakened,theairwaydeviceremoved,and
thepatientshiftedtotherecoveryroom.

Allpatientsunderwentastructuredinterviewat12,24,and36hpostoperativelywhichwasconductedbyan
anesthesiaresidentwhodidnotknowthenatureofairwaymanagementdeviceused.Patientswereaskedabout
sorethroat(constantpainindependentofswallowing),hoarseness,andorpainduringphonation(asvoice
complaints)andaboutdysphagia/odynophagia(difficulty/painonswallowing).Severityofpainduetosorethroat
andodynophagiawererecordedinthevisualanalogpainscale(VAS).
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MannWhitneyUteststatisticwasusedwhenthevariableswereordinal/interval,Fisher'sexacttestwasusedfor
smallsamplesizesandgoodnessoffittothedatawastestedusingChisquare(2)test.AtwotailedP<0.05was
consideredsignificant.ThestatisticalanalysiswasdoneusingSPSSversion16(SPSS,Inc.,Chicago,IL).

RESULTS Goto:

Outofthe170patientsoriginallyenrolledinthestudy,12patientscouldnotbefollowedup(4intheLGroupand
8intheETTGroup)astheyweredischargedbeforetheinterviewcouldbecompleted.Hence,thetotalstudy
populationwasonly158.ScoreontheVASscalewascategorizedtomild(12)moderate(35)andsevere(>6).
Boththegroupswerecomparableintermsofage,weight,durationofanesthesia,andanestheticmanagement.

Agedistributionbetweenthetwoairwaysmanagementtechniqueswerecloselymatched(P=0.749).Regarding
voicecomplaints,patientsweresortedintothreecategories(novoicecomplaintshoarsenessonlyandpainduring
speech).At12hsignificantlymorepatients(P<0.01)whowereintubatedwiththeETT(21outof77)hada
hoarsevoicethanthoseintheL(14outof81)group(27.3vs.17.3%).About9.0%oftheEGroup(7outof77)
hadpainduringphonationascomparedtononefortheLGroup.After24hcomplainsofhoarsenessintheE
Groupdecreasedto14.3%(11outof77)andpainonphonationdecreasedto2.6%(2outof77)while8.6%ofthe
patients(7outof81)intheLGrouphadhoarseness,nonehadpainonphonation.However,thisdifferencewas
notsignificant(P>0.05).After36h10.4%oftheEGroup(8outof77)hadhoarsenesswhereasonly1.2%(1out
of81)oftheLMAGrouphad(P<0.05).Nonehadpainonphonationat36h[Table1].

Table1
Comparisonofhoarseness/painonspeakingbasedongroup

Painonswallowingisanotherdistressingsequelofairwaymanagement.Agreaternumberofpatientswhowerein
theLGroup(27outof81)hadpainduringswallowingat12h(mildpain18.5%,moderatepain14.8%)compared
tothose(24outof77)intheEGroup(mildpain31.2%,nonehadmoderatepain).However,thisdifferencewas
notfoundtobesignificant(P>0.05).At24hpatientsintheLGroup(22outof81)hadsignificantly(P<0.01)
morepain(mild22.2%moderate4.9%)thanintheE(6outof77)Group(mild7.8%).Thisdifference(P<0.01)
continuedupto36hLGroup(mildpain16%EGroupnopainreported).Though31%ofpatientsintheEGroup
(almostsameasLGroup)hadpainonswallowingat12h,itreducedsignificantlyinthenext24handnopainwas
reportedat36h[Table2].

Table2
Comparisonofpainonswallowingbasedongroup

At12hcomplaintsofasorethroatweresignificantlymoreintheEGroup(47outof77)thanintheL(29outof
81)Group(61.1%vs.35.8%,P<0.01).TheseveritywasalsomoreintheEGroup(moderatepain13%vs.
4.9%).However,at24and36htherewerenosignificantdifferencesbetweenthetwogroupsalthoughalarger
percentageoftheEGrouphadasorethroat(35.15%vs.23.5%and22.1%vs.14.8%,respectively)[Table3].

Table3
Comparisonofasorethroatbasedongroup

PerioperativeeventsisabroadbasedtermintowhichalltheperioperativefactorsthatcouldplayaroleinPLM
havebeenplaced.Themainroleofthisvariablewastofilteroutconfoundingfactors.Comparisonofperioperative
eventsbasedonthegroupdoesnotshowanysignificantdifferencewithP=0.511(16.9%vs.21%and83.1%vs.
79%)buttraumaduringintubation/LMAinsertionshowedasignificantdifference.Only16.9%ofpatientsintheE
Groupshowedbloodoncuffcomparedto38.3%intheLGroup[P=0.003,Table4].Thesignificanceof
perioperativeeventswascheckedonlywiththeincidenceofthecomplaintsat12h.Fisher'sexacttestwasusedas
therewerecellsinthe22contingencytablewhichhadlessnumberofobservationsprecludingtheuseof2test.
Asperthestudy,therewasnosignificantimpactofvariousintraoperativeincidentsontheoutcomevariables
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exceptinthecomplaintsofasorethroatintheEGroupwheretheP=0.0123[Table5].Therewasalsoa
significantcorrelationbetweentraumaticinsertionandsorethroat(P<0.001),painonswallowing(P<0.003)in
theLGroup,whichcouldbeduetodirecttrauma[Tables6and7].

Table4
Comparisonoftraumaduringintubation/insertionbasedongroup

Table5
Comparisonofperioperativeincidentsontheincidenceofasorethroatin
theendotrachealtubegroupat12h

Table6
Comparisonoftraumaticinsertionontheincidenceofpainonswallowingin
thelaryngealmaskairwaygroupat12h

Table7
Comparisonoftraumaticinsertionontheincidenceofasorethroatinthe
laryngealmaskairwaygroupat12h

DISCUSSION Goto:

Asorethroatassociatedwithintubationcanbeattributedtomultiplefactorssuchastubesize,[6]sex,[3,7]typeof
surgeries,[3]cuffdesign,[8]useoflocalanesthetic,andlubricationforthecuff.[9]Ourincidenceofasorethroat
(61.1%at12h)fortheETTwashigherthanthereportof40%(n=809)incidencebyBiroetal.[10]butlessthan
Raduetal.[11]whereanincidenceof74%,butat6h.Thegreaterandmoresignificantincidenceofasorethroatin
theEGroupinourstudycanbebecauseoftheplacementofETTtomoresensitivetissuesofthelarynxandthe
tracheawhichcausessensitizationtopain,thuscontributingtoapostoperativesorethroat.[12]Christensenetal.[7]
intheirstudyreportedalowerincidenceofasorethroat(14.4%)whereasOgataetal.[13]foundanincidenceofa
sorethroattobe55%and45%,4and24haftersurgery.

Hoarsenessisacommoncomplicationafterendotrachealintubation.Yamanakaetal.[14]observedanincidenceof
49%onthedayofsurgery,29%,11%,and0.8%on1,3,and7postoperativedays,respectively.Themostcommon
causeforpostoperativehoarsenessinpatientsundergoingproceduresthatdonotinvolvetheheadandneckis
swellingofthevocalcords.[15]Vocalcordparalysisandparesishavebeenreportedaftertrachealintubation
despitetheintubationbeingatraumaticandthesiteofthesurgeryremotefromtheheadandneck.[16,17]The
incidenceofvocalcordgranulomathefollowingintubationisreportedtobebetween1in800and1in20,000.[18]
Arytenoiddislocationwhichisararecomplicationfollowingtrachealintubationthatwillresultinprolonged
hoarsenessofvoicehasalsobeenreported.[14]

AsorethroatduetoLMAcanbemultifactorial,anditsincidencecanbeinfluencedbythedepthofanesthesiaat
themomentofinsertion,methodofinsertion,thenumberofattempts,andthepresenceofhumidifiermoisture
exchangerinthecircuit.[19]TheincidenceofasorethroatwiththeuseofLMAvarieswidelyandmaybe
attributabletodifferentmethodologies.[8,20,21]Severalstudieshaveevaluatedinsertiontechniques,lubricantsand
theeffectofcuffpressurelimitationintermsofeaseofinsertionoftheLMA,pharyngealtrauma,andpostoperative
throatsymptoms.[22,23]However,whatwassurprisinginourstudywasahigherincidenceofasorethroatinL
Group(35.8%)astheyunderwentcontrolledventilation,whichmightrequirehighersealingpressuresforthecuff
ascomparedtospontaneouslybreathingpatients,thusresultinginmoremucosalischemicinjury.Someauthors[19]
foundnorelationshipbetweencuffpressureandPLM,whereasothers[24,25]cametotheconclusionthat
minimizingcuffpressuresledtodecreasedsorethroat.

Inametaanalysisofrandomizedcontroltrials[26]comparingLMAwithETT,lessincidenceofvoiceproblems
withLMAwasfoundwhichcanbeofadvantagetoprofessionalvoiceusers.LMAcancausetransientchangesin
vocalcordfunction.[27]Atotalof14nerveinjurieshasbeenreporteduntil2004[28,29]followingtheuseofLMA
namelyrecurrent(7),hypoglossal(5)andlingual(2).Inallthesecasessize,3and4LMA'swereused.Itshouldbe
pointedoutthat,whenperfectlypositioned,theLMAlieswiththetiprestingagainsttheupperesophageal
sphincter,withthesidesfacingthepyriformfossae.

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Thisstudywasdesignedmainlyforthepresenceorabsenceofaspecificcomplaintratherthantheirseverity.For
havinguniformityinthedurationoftheairwaydeviceplacement,weconfinedourstudypopulationto
mastectomieswhichcanbeconsideredasalimitation.Amuchgeneralizedstudyincludingmalesexandpediatric
populationwithvaryingdurationoftheprocedureisrequiredtofurthersubstantiateourfindings.Anotherlimitation
ofthisstudywasitlackedenoughpowertoestimatethemoreseverevoicecomplaints,asitwillrequireamuch
largersamplesize.Inourstudy,therewasasignificantincidenceoftraumafollowingLMAinsertionevenwith
adequaterelaxationandanestheticdepth.Itcan,therefore,belogicallyinferredthattraumaislikelytobegreater
whenadequaterelaxationandanestheticdeptharenotprovided.Toreducetrauma,perhapsMPclassificationcan
alsobeconsideredwhileselectingthesizeofLMA.

CONCLUSIONS Goto:

BothETTandLMAcancausesignificantPLMfollowingGAwhichcanaffectpatientcomplianceandqualityof
care.ThoughtheincidenceofdysphagiaandodynophagiawerefoundtobemorewithLMA,hoarseness,andsore
throatwhicharemajordeterminantsforprolongedhospitalstayandpatientdiscomfortwerefoundtobemuch
reducedinourstudywhencomparedwithETT.Reassuranceandsymptomaticmanagementforswallowing
problemsareallthatisrequiredtoreducepatient'sanxiety.DefinitelyLMAisabetteralternativewhenused
judiciously,gently,andunderadequateanestheticdepthtoreducetheincidenceofPLMfurther.Cuffpressure
monitoringshouldberecommendedasastandardpracticetoreduceadverseoutcomesofPLM.

Financialsupportandsponsorship
Nil.

Conflictsofinterest

Therearenoconflictsofinterest

Acknowledgment Goto:

WeacknowledgeDr.Aleyamma,AdditionalProfessorinEpidemiologyandStatistics,forthestatisticalhelpfrom
RegionalCancerCentre,Thiruvananthapuram,Kerala,India.

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