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REVISTA

BRASILEIRA

DE

ANESTESIOLOGIA

OfficialPublicationoftheBrazilianSocietyofAnesthesiology

www.sba.com.br

SCIENTIFIC

ARTICLE

Comparison

of

the

i-gel

TM

and

the

Laryngeal

Mask

Airway

Classic

TM

in

terms

of

clinical

performance

Reyhan

Polat

,

Gözde

Bumin

Aydin,

Jülide

Ergil,

Murat

Sayin,

Tu˘

gba

Kokulu, ˙Ibrahim

Öztürk

DepartmentofAnesthesiology,DiskapiYildirimBeyazitResearchandTrainingHospitalDiskapi,Ankara,Turkey

Received18January2014;accepted5February2014 Availableonline6March2014

KEYWORDS

LaryngealMask

AirwayClassic;

i-gel;

Supraglotticairway

devices

Abstract

Purpose: Thei-gelTM isoneofthesecondgenerationsupraglotticairwaydevices.Our study wasdesignedtocomparethei-gelandtheLaryngealMaskAirwayClassicTMwithrespecttothe clinicalperformance.

Methods:Wecomparedtheperformanceofthei-gelwiththatoftheLaryngealMaskAirway Classic in 120patients undergoingurologic surgeryduringgeneral anesthesiawithout mus-clerelaxantwithrespecttothenumberofattemptsforsuccessfulinsertion,insertiontime, peak airway pressure,incidence ofregurgitation, fiberoptic glotticview andpostoperative complications.Secondgenerationsupraglotticairwaydeviceswereinsertedbythesame anes-thesiologist,experienced inuse ofbothdevices (>200uses andfirsttime failurerate<5%). Methylenebluemethodwasusedtodetectgastricregurgitation.

Results:There was no statisticaldifference between thetwo groups regarding thesuccess ofinsertionofsecondgeneration supraglotticairwaydevice(p=0.951).Thelaryngeal mask insertiontime forthei-gel groupwas significantlyshorterthanthatfor theLaryngealMask Airway Classic group(11.6±2.4sversus 13.1±1.8s[p=0.001]). Thefiberoptic glotticview scoresforthei-gelgroupwassignificantlybetterthanthatfortheonesfortheLaryngealMask AirwayClassicgroup(p=0.001).Onfiberopticview,therewasnosignofmethylenebluedye atanytimepoint ineithergroup.In addition,therewas nodifferencebetweenthegroups inpatient responseregardingthepresenceofasorethroatwhen questioned24hafterthe procedure(p=0.752).

Conclusion: Both devices had good performance with low postoperative complications and withoutoccurrenceofregurgitation.Thei-gelprovidedashorterinsertiontimeandabetter fiberopticviewthantheLaryngealMaskAirwayClassic.

© 2014SociedadeBrasileirade Anestesiologia.Publishedby ElsevierEditoraLtda.Allrights reserved.

Correspondingauthor.

E-mail:reyhanp9@gmail.com(R.Polat).

0104-0014/$–seefrontmatter©2014SociedadeBrasileiradeAnestesiologia.PublishedbyElsevierEditoraLtda.Allrightsreserved.

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PALAVRAS-CHAVE

Máscaralaríngea

clássica; i-gel; Dispositivos supraglóticos

Comparac¸ãodamáscaralaríngeai-gel(i-gelTM)comamáscaralaríngeaclássica

(LMA-ClassicTM)emrelac¸ãoaodesempenhoclínico

Resumo

Justificativaeobjetivo:Ai-geléumdosdispositivossupraglóticosdesegundagerac¸ãoparao manejodasviasaéreas.Nossoestudofoiprojetadoparacompararai-gelTMeamáscaralaríngea clássica(LaryngealMaskAirwayClassicTM,LMA-C)emrelac¸ãoaodesempenhoclínico.

Métodos: Avaliamososdesempenhosdei-geleLMA-Cem120pacientessubmetidosàcirurgia urológicasobanestesiageralsemrelaxantemuscular.Comparamosonúmerodetentativasde inserc¸ãobem-sucedidas,otempodeinserc¸ão,apressãodepicodasviasaéreas,a incidên-ciaderegurgitac¸ão, avisibilidade daglotecomousode fibraópticaeascomplicac¸õesno pós-operatório.Osdispositivossupraglóticosdesegundagerac¸ãoforaminseridospelomesmo anestesiologistacomexperiência naaplicac¸ãodeambos os dispositivos(> 200aplicac¸ões e taxadefalhanaprimeiratentativa<5%).Ocoranteazuldemetilenofoiusadoparadetectar regurgitac¸ãogástrica.

Resultados: Nãohouvediferenc¸a estatísticaentreos doisgrupos em relac¸ãoao sucesso da inserc¸ão do dispositivo supraglótico de segunda gerac¸ão (p=0,951). O tempo de inserc¸ão da máscara laríngea no grupo i-gel foi significativamente menor do que no grupo LMA-C (11,6±2,4segundosvs.13,1±1,8segundos,p=0,001).Oescoredevisibilidade daglotevia fibraópticadogrupoi-gelfoisignificativamentemelhordoqueodogrupoLMA-C(p=0,001). Navisãoviafibraótica,sinaisdocoranteazuldemetilenonãoforamobservadosemqualquer momentoemambososgrupos.Alémdisso,não houvediferenc¸aentreasrespostasdos gru-posquandoperguntadossobreapresenc¸adedordegarganta24horasapósoprocedimento (p=0,752).

Conclusão:Ambososdispositivosapresentarambom desempenho,compoucascomplicac¸ões nopós-operatórioesemocorrênciaderegurgitac¸ão.Amáscaralaríngeai-gelproporcionouum tempodeinserc¸ãomaiscurtoeumavisãoviafibraópticamelhordoqueaLMA-C.

©2014SociedadeBrasileiradeAnestesiologia.PublicadoporElsevierEditoraLtda.Todosos direitosreservados.

Introduction

IntroductionofLaryngealMaskAirway(LMAClassicTM;

[LMA-C] Intavent Orthofix, UK), has changed the practice of

maintaining safe airway.1 Since then, supraglottic airway

devices(SGADs) havebeen usedsuccessfullyandsafely in

anestheticpracticewith variousmodels,and have

under-gonerapiddevelopment.2,3AlmostallSGADs,includingthe

LMA-C,useaninflatablecufftowedgeintotheupper esoph-agusandprovideaperilaryngealseal.4Accuratepositioning

andadequatepressureandvolumewithinthecuffare

fun-damentaltoachieve optimal function, and toreduce the

complications. A limiting factor for the use of SGAD is

thelackofairwayprotectionfromgastriccontents.5,6

Sev-eralSGADsarenowmarketedthatarespecificallydesigned

toreduce therisk of aspiration.The i-gelTM (Intersurgical

Ltd.,UK)is oneofthesecondgenerationSGADsproduced

forthispurpose. The cuffofthe i-gelisconstructed from

medical-grade thermoplastic elastomer (styrene ethylene

butadienestyrene)whichdoesnotrequireinflatingthecuff

or adjustingintra-cuff pressure.Its designenables a

mir-roredimpressionofthepharyngealandlaryngealstructures

andprovidesaperilaryngealsealwithoutcuffinflation.The potentialadvantagesofthei-gelareeasyandrapidinsertion

anda reductionin the risk of pharyngealtissue

compres-sionduetohigh cuffpressure.Moreover, ithasan inbuilt

drainage channel, which allows the insertion of a gastric

tube(maximum14Fgauge),tofacilitatetheefluxofgastric

fluidandgas.

This studycompares theclinical performance ofthe

i-gelwiththeLMA-Cintermsofinsertiontime,thenumber

ofattemptsforsuccessfulinsertion,peakairwaypressure,

fiberopticglotticview,incidenceofregurgitation,and

post-operative complicationswhich haveneverbeen compared

inarandomized-prospectivestudyinadultsinvivobefore.

Methods

ThisstudywasconductedbetweenJuneandSeptember2013

at DiskapiYildirim BeyazitResearchandTrainingHospital.

Thestudy(ref:06/27,date:12/17/2012)wasapprovedby

alocalresearchethicscommittee.Atotalof120patients,

whounderwenturologicsurgeryinlithotomypositionunder

general anesthesia with ASA physical status I---III (aged

18---70 years, weight 50---90kg), were assessed and

writ-teninformedconsentwastakenfromallpatientsenrolled

in the study. Patients with a history of gastroesophageal

reflux,hiatalhernia,previousgastricsurgeryorbodymass

index(BMI)>35kg/m2,andthosewhotakemedicationsfor

disorders of gastrointestinal motility were excluded from

the study.The patients were randomizedintotwogroups

(groupLMA-C,n=60,orgroupi-gel,n=60)bya

computer-generatedrandomnumbertable.TheinsertionofSGADswas

(3)

use of both devices(>200 uses andfirst timefailure rate <5%).

All patients’ demographic parameters (gender, age,

weight, height and body mass index), and the duration

of surgery were recorded. Patients were premedicated

with0.04mg/kgmidazolamivapproximately30minbefore

inductionofanesthesia.Agelatincapsulecontaining

methy-lene blue powder (25mg in lactose and 30mL of water)

wasingestedorallyinsittingpositionbythepatients10min beforeinductionofanesthesia.Thegelatincapsuledissolves

in wateror acidic pH 1---5solution within5min and turns

the gastric contents blue.7,8 Patient heart rate (HR) by a

three-channelECG,noninvasiveblood pressure,bispectral

index (BIS) (A-200 BIS monitoring system; Aspect Medical

systems,BISXP;Framingham,MA,USA),andpulseoximetry

weremonitored.Anestheticmanagementwasstandardized

according to the following protocol. Patients were

pre-oxygenated for 2min, and anesthesia was induced with

propofol(2---2.5mg/kg)andfentanyl(1.5---2␮g/kg).Inorder

toprovideconsistentconditions,insertionoftheSGADwas

madewhentheBISwasbelow60.BISvalueswerekept

sta-blebyinhalationalanesthesiathroughoutthestudyperiod.

Each devicewaslubricatedwithawater-based agentand

insertedaccordingtothemanufacturer’srecommendations.

Sizeselectionofthei-gelor LMA-Cdependedonpatient’s

weightinaccordancewiththeguidelines.TheLMA-Ccuffs

wereinflateduntiltheairleaksoundcomingfromthemouth

ceased (≤45cm3air). In orderto maintain adequate cuff

pressureforLMA-C,cuffpressurewasmaintainedinbyusing

ahandheldpressuregauge(VBMMedizintechnikGmbH,Sulz

a.N.,Germany).

Anesthesia wasmaintained with 1.5---2% sevoflurane in

50% oxygen---air mixture without using any neuromuscular

blockers,andremifentanilinfusionwasstartedatadoseof

0.2---0.3␮g/kg/min.Manualbagventilationwasmaintained

inallpatientsthroughacirclesystemuntilinsertionofSGAD

andvalidationofplacement.

InordertoinserttheSGAD,amaximumofthreeattempts

wasmadeforeachgroup.Ifitwasnotpossibletoventilate

the lungs, the following adjustments were allowed: neck

extensionorflexion,chin lift,jawthrustandgentle

push-ingor pullingof thedevice. Wheninsertion ofboth SGAD

modelsfailed,thesubjectwasexcludedfromthestudyand

theairwaywasmaintainedby an endotrachealtube.

Cor-rectinsertionwasassessedbyproperchestexpansion,the

presence of a curved CO2 wave on the capnography, the

absenceofaudibleleak,andlackofgastricinsufflation.The

presenceofgastric insufflationwasdeterminedby

epigas-tric auscultation.In both groups, insertionsuccess of the

SGAD(thenumberofairwaymanipulations),timerequired

to establish the airway (the total time from grasping of

the device toobserving asquare wave capnographtrace)

andcomplicationssuchaslaryngospasm,apnea,orhiccups

were recorded. After obtaining an effective airway, the

devicewasconnectedtoacirclebreathingsystem(Primus,

Drager,Lubek,Germany).Thelungswereventilatedwitha

tidalvolumeof 7mLkg−1,arespiratoryrateof12breaths

per minute, and I:E ratio of 1:2 and peak airway

pres-sure of approximately12---20cmH2O in volume controlled

mode. Peak airway pressure values were recorded. After

ensuringsatisfactoryventilation,theanatomicalpositionof

LMA-Candi-gelwasassessedusingafiberopticendoscope

(2.8mm;Olympus,Tokyo,Japan)viatheairwaytubeofthe

device.Thefiberscopewasalwayskeptstraight

(anatomi-calposition)tomaintaincontroloverthetip.Thetipofthe

fiberscopewaspositionedjustabovethebarsoftheLMA-C

ori-gel.Theviewviatheairwaychannelswasscoredas

fol-lows:Grade4,onlyvocalcordsareviewed;Grade3,vocal

cordsand posterior epiglottis areviewed; Grade 2, vocal

cordsandanteriorepiglottisareviewed;Grade1,cordsare

notviewedbutfunctioningadequately.9,10

To prevent false-positive regurgitation,the

oropharyn-gealcavity wasinspected for blue dye. Afterinsertion of

SGAD,thepresenceorabsenceofbluedyeinthebowlwas

assessedusingafiberscope.Additionally, beforeSGADwas

removed,fiberscopywasrepeatedagaintofindouttracesof methyleneblueinallthepatientsattheendofthe

surger-ies.AfterremovalofSGAD,thedevicesusedforfiberscopy

wereinspectedvisuallyfortraceofbluestainingandblood byoneoftheinvestigatorsandtheresultsofthese

inspec-tionswererecorded.

Once surgerywascompleted, sevofluraneand

remifen-tanilwerediscontinued.Whenthepatientwasabletoopen

hisorhermouthfollowingourcommand,theairwaydevice

wasremovedafterpharyngealsuctioningandliftingofthe

jaw.Then,thepatientwasgiven100%oxygenviafacemask

for10min.

The patients were interviewed in the post-anesthetic

careunitbynurseswhowereblindtostudy,withrespectto

thepresenceofsorethroatanddysphagia.Whenmodified

Aldretescoreswere10andabove,thepatientswere

trans-ferredtotheirrooms.Twenty-fourhoursaftersurgery,the

patientswereaskedonemoretimeiftheyhadsorethroat

anddysphagia.

Statisticalanalysis

Thesamplesizeof55pergroupwasdeterminedbypower

analysis;duetothepreliminarystudyresultsofdecreasein

insertiontimemeasurements,whendeltawasassumedtobe

1.25andSDas2.0,with90%powerand˛:0.05,thesample

size(n)wascalculatedtobeminimum55for eachgroup.

Consideringa10%drop-outrate,thenumberofsubjectswas

calculatedtobe60ineachgroup.

All statistical analyses were performed by using SPSS

15.0softwarepackage(SPSSInc.,Chicago,IL,USA).Ttest

forindependentsampleswasusedtocomparetwogroups

fordatawithnormaldistributionandMann---WhitneyUtest

wasusedforcomparingdatawithnon-normaldistribution.

Yates continuity correction test, Fisher’s exact test and

Fisher---Freeman---Haltontest were usedfor comparisonof

qualitativedata.

Alldatawere summarizedasmean±SDfor continuous

variables,numbers and percentages for categorical

varia-bles.Ap<0.05wasacceptedasstatisticallysignificant.

Results

Bothgroups were comparablewith respectto age,

male-to-femaleratio,height,weight,andbodymassindex.The

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Table1 Baselinecharacteristicsofpatientswhounderwentanesthesiawiththei-gelorLaryngealMaskAirwayClassic(LMA-C). Dataareexpressedasmean±SD.

i-gel(n=59) LMA-C(n=59) p

Age(years) 48±15 50±17 0.619

Weight(kg) 77.9±10.5 75.9±14.1 0.384

Height(cm) 169.1±9.9 168.4±8.1 0.656

Bodymassindex(kg/m2) 27.3±3.5 26.7±4.4 0.436

Durationofsurgery(min) 48.6±16.1 47.5±23.5 0.753

Table2 Comparativedataforthei-gelandLaryngealMaskAirwayClassic(LMA-C).Dataareexpressedasnumber(proportion) ormean±SD.

i-gel(n=59) LMA-C(n=59) p

Insertiontime(s) 11.6±2.4 13.1±1.8 0.001

Peakairwaypressure(cmH2O) 12.4±2.2 12.6±2.4 0.753

Glotticviewa 0.001

4 19(32.2%) 1(1.7%)

3 16(27.1%) 10(16.9%)

2 14(23.7%) 19(32.2%)

1 10(16.9%) 29(49.2%)

aTheglotticviewviafiberopticexaminationwasscoredusing thefollowing:score 4,clearviewofthevocalcords;score3,only

arytenoidvisible;score2,onlyepiglottisvisible;score1,larynxnotvisible.

120 patients

LMA-C (n=60)

1st attempt 53/60(89.8%)

2nd attempt 1/60(1.69%)

3rd attempt 5/60(8.4%) 3rd attempt

3/60(5%) 2nd attempt

3/60(5%) 1st attempt 53/60(89.8%)

i-gel (n=60)

Failure 1/60 Failure 1/60

Figure1 Flowchartofthestudy,showingthesubdivisioninto groupscorrespondingtoeachsupraglotticairwaydevice.

Inthei-gelgroup,theSGADwassuccessfullyinsertedin

53patients (89.8%)at thefirstattempt, inthreepatients

(5.0%)atthesecondattempt,andinthreepatients(5.0%)

at the third attempt. In the LMA-C group, the SGAD was

successfully inserted in 53 patients (89.8%) at the first

attempt,inonepatient(1.69%)atthesecondattempt,and

infivepatients(8.4%)atthethirdattempt.Thereweretwo

patientsinwhomneitherthei-gelnortheLMA-Ccouldbe

inserted.Therewasnostatistical differencebetween two

groupsregardingtosuccessofinsertionofSGAD(p=0.951) (Fig.1).

Duration of laryngeal mask insertion time in the i-gel

group wassignificantly shorter than that in group LMA-C.

Themeanlaryngealmask insertiontimeswere11.6±2.4s

in i-gel and13.1±1.8s in LMA-C group (p=0.001). Three

patients in group LMA-C (5.0%) andfive patients in group

i-gel (8.4%) suffered from hiccups, which was the only

complication(p=0.717).Nolaryngospasmandapneawere

observedinanyofthepatients.

Peak airway pressure values measured by the

venti-lator were remarkably close for the two groups. The

mean peak airway pressures were 12.4±2.2cmH2O and

12.6±2.4cmH2Oin i-gelgroup andLMA-C group,

respec-tively (p=0.753). The fiberoptic viewscores for the i-gel groupweresignificantlybetterthanthatfortheLMA-Cgroup (p=0.001)(Table2).

Therewerenosignsofmethylenebluedyeinfiberoptic

viewatbeginning,afterinsertionofdevices,andjustbefore

removalofdevicesinbothgroups.Bluishdiscolorationwas

notseenafterremovalofanyofthedevices.

Bloodstainingwasencounteredrarelyafterremovalof

the devices in both groups; however, it was comparable

betweenthegroups(5ingroupi-gel[8.5%]and3ingroup

LMA-C[5.1%])(p=0.717).Postoperativeinterviewrevealed

a notable incidence of sore throat in both groups. Ten

patients of group i-gel (16.9%) and five patients of group

LMA-C(8.5%)reportedsorethroatatthepostanesthesiacare

unit(p=0.169).Also,therewasnodifferencebetweenthe

groupsregardingsorethroatat24hquestioning(p=0.752) (Table3).

Discussion

Ourresultsdemonstratethati-gelhasasimilarperformance

intermsofinsertionsuccess,peakairwaypressure,the

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Table3 Sideeffectsobservedinstudygroups.

i-gel(n=59) LMA-C(n=59) p

Signsofregurgitation 0 0

Bloodstaining 5(8.5%) 3(5.1%) 0.717

SorethroatinPACU 10(16.9%) 5(8.5%) 0.169

Sorethroatafter24h 1(1.7%) 1(1.7%) 0.752

Hiccups 5(8.5%) 3(5.0%) 0.717

LMA-C,LaryngealMaskAirwayClassic.

thenumberofgastricregurgitationcomparedwiththe

LMA-C.However,i-gelhasadvantagesovertheLMA-Cintermsof

shorterinsertiontimesandimprovedfiberopticviewsofthe

glottis.

Our study showed high success rates of insertion with

both devices,which is inagreement withdataexistingin

the literature.In Gatward et al.11 study,they obtained a

86%successrateini-gelinsertionatthefirstattempt,and

theoverallinsertionsuccess ratewas100%,similartothe

LMA-CandtheprosealLMA(PLMA).Alietal.12hadasuccess

rateof77%forLMA-Cinsertionandasuccessrateof88.5%

forLMA-Supremeatthefirstattemptintheirstudy.Richez13

alsoshowedacomparablesuccessrateforplacementofthe

i-gel.Incontrasttothesestudies,inAminietal.’sstudy14

comparingi-gelandintersurgicalsolusLMA,theyfoundthat

i-gelgrouprequiredmoreinterventionsontheairwaythan

theintersurgicalsolusLMAgroup.Theythoughtitmightbe

becauseof lack of experienceof theanesthesiologists. In

ourstudy,i-gelhasasimilarperformanceintermsof

inser-tionsuccesscomparedwithLMA-C,andnointerventionwas

requiredduringmaintenanceofanesthesia.SGADswere

suc-cessfullyinsertedin89.8% ofpatientsat thefirstattempt

intheLMA-Candinthei-gelgroup.Thismaybeexplained

by thepresence ofexperienced instructorin placingboth

SGADs.

Ourresultsdemonstrate shorterinsertiontimesfor the

i-gelcomparedwiththetimesforLMA-C,probablybecause

ofthefactthatlessflexiblestemofthei-gelmakes inser-tioneasierandwithoutanyneedforcuffinflation.Insertion

success and shorter insertion times influence the

feasi-bility of SGADs, as determined by Uppal and Amini and

colleagues14,15;wefoundthattheinsertiontimewasshorter

inthei-gelgroupbutwedidnotfindanysignificantclinical differenceinthisregard.

Many investigators have demonstrated that there are

no significant differences in oropharyngeal leak pressure

between the i-gel and LMA-Supreme.16,17 Chen et al.’s18

meta-analyses revealed that there were similar

orop-haryngeal leak pressures during anesthesia between the

LMA-Supreme and the i-gel. In some studies, the LMA

Supremeisreportedtohavehigheroropharyngealleak

pres-surethantheLMA-C.12,17Althoughthei-geldoesnothavean

inflatablecuffandthusitishardertoadjusttheseal,given

Chenetal.’smeta-analysesoforopharyngealleakpressures

of i-geland LMA-Supremeand variousinvestigators’

com-parisons of oropharyngeal leak pressures of LMA Supreme

andLMA-C, itcanbededuced thati-gelmight have same

orhigheramountsoforopharyngealleakpressurethan

LMA-C.12,16---19 Further studies onthe most commonalternative

SGADs suggest thata meanpeakairway pressureof more

than20cmH2Oincreasestheriskofleakagewithresultant

insufficientventilationandincreasedriskofaspiration.20,21

In our study, the i-gel demonstrated similar peak airway

pressures(mean12cmH2O)with7mLkg−1tidalvolume,to

the LMA-C and was comparable with the LMA-C in other

studiesandlessthan20cmH2O.22

In ourstudy, we hadbetter glottic view in i-gelgroup

byfiberscopyandsimilarresultswerereportedinacohort

studyperformed by Beringeret al.23 as wellas anumber

ofadultstudies.17,18 Wethinkthatthereasonfor

fiberop-ticview of glottisnot being goodenough in LMA-C group

mightbeduetomalpositioncausedbycuffofLMA-C.The

fiberopticviewdependsonthehypopharyngealpositionof

theSGADandwhethertheepiglottisisfoldeddownduring

insertionornot.However,itwasshownthatthereisno

cor-relationbetweenfiberopticviewandSGAD’sfunction.The

fiberopticscoreconfirmsthattheSGADoccupiesafavorable

anatomicallocationtoensureunimpededventilation,with

lowerleakpressuresandlessgastricinsufflation.23

In manystudies that investigate SGADregurgitation,it

has been shown that the presence of SGAD results in a

reaction in the pharynx which causes a reflex relaxation

attheloweresophagealsphincteraswellasadecreasein

loweresophageal sphincterpressure.7,8,24 This mechanism

mightbemoreactiveduringsuperficialanesthesia.

Inade-quateanesthesialevelandinexperiencewiththeSGADuse

mayincreasetherisk ofregurgitation.Bapatetal.25

con-cludedthattheydidnotencounteranyregurgitationeven

inpatientswithhighriskintheirstudybecauseofan experi-encedSGADuser.Anotherstudywith280patientsusingi-gel

demonstratedthatthreepatientssufferedfrom

regurgita-tionandoneofthemresulted inaspiration.Thispatient’s

supraglotticdevice wasreplaced by a medicalstudent.26

Brimacombe22 has suggested two distinct learning curves

in the use of SGAD, and we believe that the high

inci-denceofregurgitationcitedintheearlierstudiesmighthave

occurred during the learning curve. We controlled depth

of anesthesia with BIS monitoring, and maintained it at

between50 and 60, withan experienced anesthesiologist

placingbothSGADs’.

The measurement of hypopharyngealpH is an another

methodtodetectgastricregurgitation,buthypopharyngeal

pH is measured at a single level and thus may not

accu-ratelyreflecttheactualincidenceofsilentregurgitation.27

Thevalidityofthemethylenebluemethodtodetect

regur-gitationisquestionable,becausedisintegrationofacapsule

in the esophagus may lead to a falsely high incidence of

regurgitation.8 Inour study,toreduce falsepositives, the

methylenebluecapsule wasingestedwith30mL waterin

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patients 10min after theingestion of thedrug in case of falsepositivebluedye.

Severallimitationsexistinthisstudy.Firstly,unblinded

observerscollectedallthedata.Secondly,the

anesthesiol-ogistinsertingtheSGADshadconsiderablymoreexperience

in inserting the LMA-C and the i-gel and this may have

introduced bias in the results. Thirdly, the devices were

usedin non-obese patients andin those without

underly-inggastrointestinalsystemdisorders.Theresultscannotbe

extrapolatedtoothergroupsofpatients.

Inconclusion,ourstudydemonstratesthatbothdevices

hadgoodperformancewithlowpostoperativecomplications

andwithoutoccurrenceofregurgitation.Thei-gelprovided

ashorterinsertion timeandabetterfiberoptic viewthan

theLMA-C.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

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Imagem

Figure 1 Flow chart of the study, showing the subdivision into groups corresponding to each supraglottic airway device.
Table 3 Side effects observed in study groups.

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