6533b7d1fe1ef96bd125d79f

RESEARCH PRODUCT

Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial.

Rupert PearseMarco RanieriTom AbbottMari-liis PakatsEdoardo PiervincenziAkshaykumar PatelBrennan KahanAndrew RhodesPriyanthi DiasRussell HewsonIb JammerMichelle ChewCesar AldecoaReitze RodsethBruce BiccardTim StephensSara PayneDavid HepworthSoeren PischkeJoerund AsvallJohn HauskenShaman JhanjiMartin RoomsNeil FlintDawn HalesTamas SzakmanyAndrew LeitchSavino SpadaroDavide ChiumelloPaul JohnstonJoyce YeungGuglielmo TellanTonny VeenithJosep MacmillanPierpaolo TerragniCaroline SanderVidya KasipandianTahania AhmadAaron LeeMarcello TammaroDanny McauleySimon SkeneRavinder VohraMatt WilsonMark EdwardsEwen GriffithsNaomi PritchardClaudia FilippiniTor AasmundstadEinar AksnesLise-merete AlpersAndreas Barratt-dueAnita DahlLinda FeldtElisa FigariEva FlåtenKaren GranheimMinna HagringHåkon HaugaaGisle KjoesenInge KlaevahaugenHarald LenzMarianne MyhreHilde OrremEmily StittTor Inge ToennessenSamuel Al-kadhimiRobert AnkerMihaela BalintLauren BarracloughEthel BlackMatt ClaytonLeonora ConneelyZara EdwardsAlex EelesMatthew EvansMichelle GerstmanNicole GreenshieldsEleanor HarveyAoife HegartyNatalie HesterJenna HutchinsonRamanathan KasivisvanathanHelen LawrenceVeronica MarshLaura MatthewsFrancesca MazzolaJamie MccannyBen MorrisonMichelle O'mahonyChing Ling PangDavid ParkinsonKatrina PirieRavishankar Rao BaikadyLouisa ShovelLorna SmithKate TathamPeter ThomasSophie UrenSusanna WalkerAlasdair WillsPrematie AndreouAlex HowsonJasmin KaurAdam LewszukEsther MolinaNirmalabaye RamsamyEmma RobertsVanessa AmaralSalma BegumSoliana BekeleRichard CashmoreCarmen CorreiaSteven DunkleyMaria FernandezAlexander FowlerAmaia GarciaMaria Della GiovampaolaKathryn GreavesBethan GriffithsRyan HainesRichard HaslopYing HuSarah HuiMarta JanuszewskaVasi ManonTim MartinShaun MayAnnamaria MinicozziEdyta NiebrzegowskaMonica OliveiraKatherine PatesFilipa SantosTasnin ShahidPaolo SimiliAlastair SomervilleEmily SubhedarRuzena UddinSophie WalkerYize WanJan WhalleyParjam ZolfaghariUna GunterGemma HodkinsonGwenllian HoweValentina BaratozziGiulia CasottoGiulia DaraiErica FerrariGiovanni MistralettiValentina PalmaverdiStefano FurlaniPaolo PrianiRiccardo RagazziMarco SalmasoMarco VerriCarlo VoltaChris NuttEmma MckayOrla O'neillJaimin PatelKatie AtterburySarah BallingerNatalie CarlingKaytie EllisJo GrestyTeresa MelodyJade MonkChloe NormanEleanor ReevesJulia SampsonPeter SuttonMarie ThomasAmy BamfordColin BerginRonald CarreraLauren CooperLiesl DespyKaren EllisEmma FellowsStephanie GoundrySamantha HarkettPeter IpTracy MasonChristopher McgheeAisling MclaughlinAoife NealMartin PopeStephanie PorterHazel SmithCatherine SnelsonElaine SpruceYlenia VigoArlo WhitehouseTony WhitehouseMaria DonatielloSergio GazzanelliMario MezzapesaMartina SavinoGiacomo SettesoldiGudrun KunstSian BirchLouise GreigHarriet NobleEvita PappaBethany PenhaligonAndrea CossuLeda FlorisDavide PireddaAlberto RaccaOlof BrattstromBente HeggelundMagnus FlodbergSandra MånssonMamoona AhmedJonathan AllenPaula BellRoman GenetuJulia GlennonJanice HanleyKaty JennerSummayyah JogiParisa MahjoobClare McgovernAnthony MurphyRoonak NazariJacki RoutledgeTrishna UttamlalSinead WardGiorgio IottiRaffaella PicchioniSilvia PomaPaolo NavalesiAndrea BruniBrunella De LeonardisEugenio GarofaloPanna PatelCarol McarthurKaren BurnsSteven PetersGiuseppe FotiSerena CalcinatiAlice GrassiSilvia VillaJohn BerridgeMuthuraj KanakarajHazel CahillGreg ForshawAndy GibsonLia GraingerKate HowardKatherine JamesZoe MurphyHelen SweetingRebecca TaitDanielle WilcockDavid YatesSean CopeAshley AllanRebecca BettsSarah CornellJulie SheriffLindsey WoodsGiacomo GrasselliMatteo BrioniLuigi CastagnaRichard Von RahdenZane FarinaSamantha GreenSimphiwe GumedeChantal RajahArisha RamkillawanSusan MougDavid AlcornCarol DaltonNatalie DickinsonJennifer EdwardsSteven HendersonErin McilveenRichard RamsaranJoanne BellLorna FlemingKathleen MonksJane ParkerSean StamperJo Stokes-densonElisa ElíasYessica GuerraJesus Rico-feijooCarlos KidelHelder FilipeGretchelle AsisYvonne GleesonAlice HarveyChristine JacksonMargaret McneilSara MingoGlykeria PakouManuel PintoStephen WrightMaite Babio-galanDavid BuckleyVerity CalderAhmad ChishtiJoseph CosgroveKatherine CullenLeigh DunnMatthew FauldsJonathan FortuneMatthew GardnerAbigail HarrisonCarole HaysGerry JonesCaroline MacfieIain MccullaghIan NesbittSuzanne O'neilCatherine PhoenixGirish RangaswamyCraig SamsonCarmen ScottTara ShresthaRita SinghGraham SoulsbyJon WaltonKimberley ZwiggelaarCeri LynchHeidi ClarkeBethan DeaconHelen IvattLeanne JonesAhmed LatifShaun OramChris PermanLisa RocheRowan DuysMargot FlintKamal BhagwanEttienne CoetzeeIvan JoubertFelipe Montoya-pelaezPradeep NavsariaGuy PickenOwen PorrillGrant StrathieThembinkosi ZunguSireesha AluriSimon ChauDeborah CooperMishell CunninghamAllison DanielsSusan HopeAlice NicholsonLaura WalkerAntonino GiarratanoGiuseppe AccursoSanti RaineriGiuseppe TricoliRichard InnesPatricia DobleJoanne HutterCorinne PawleyMoira TaitMark HamiltonEdward AndradeVeronica BarnesClaire DaltonCarlos DelgadoSarah Farnell-wardHelen FarrahGeraldine GrayAoife HegartyLuisa HowlettGipsy JosephMonika KrupaSusannah LeaverJoao MacedoKaren MaherJohannes MellinghoffRachel OguntimehinJoel PereiraFrances RobinsonChristine RyanNirav ShahPaula ShirleyAlexandra TorborgThuli BiyaseLeanne DrummondBelinda KuselMbalenhle MbuyisaSivuyisiwe SolalaJenna TaylorAdanma Ezihe-ejioforMaame Aduse-pokuGary ColvilleLouise DaviesSoo KangAlex PhillipsJustin Kirk-bayleyLeigh KelliherPaula CarvelliGokce DaysalMatthew DickinsonNancileigh DoyleChristina HughesLaura MontagueElizabeth PotterArmorel SalbergSheena SibugSinduja SivarajanMilo ThomsonNichola WakefordMonica RoccoDaniela AlampiDaniel ConwayRichard ClarkJashmin MariaFiona PomeroyTanviha QuraishiAbigail WilliamsSrikanth ChukkambotlaCaroline AherneDonna Harrison-briggsJill FitchettStephen DuberleyAndrea ZanoniDaniela CardinaleClaudia RighiMark BluntTracy FullerRuth HodgsonMelissa RosbergenAndrew BrennanLouise AkeroydVictoria BoardmanChristopher BullMike CarrickIan ChaddertonSarah CooperSarah GoellnerLaura GrahamCarl IlyasJames KingMuhammad LakloukLawton T.Christopher MacrowMichael MunroAdam NeepMartin NortheyVictoria PeacockKate PyeLydia RadleyJames SiraBeth SmithsonStuart SyddallDavid ToothThomas WhiteSindre HoelElin AakreMonica BakkeTone HoivikArystarch MakowskiHarry AlcockSean CardosoSamantha CoetzeeMary EverettMohamed IbrahimChristina KouridakiVongayi OgbeideElisabetta BertelliniValentina BertolottiAntonio BuonoMaria FanigliuloRam KumarNicole RichardsAlisha AllanaSamantha BacciarelliHelen BarkerJessica De BoisIsabel BradleyJennifer CrooksPeter DaumAlex FebenLizzie GannonSarah KiplingAndrew PeetamsinghCharlotte QuaminaSahiba SethiHarry SivadhasKathryn SollestaAndrew SwainEvalyn TanJoan WillisMaggie ZouJulius CranshawNina BarrattKatie BowmanDebbie BranneyMaria LettsSally PittsChristopher DaySarah BenyonSara EddyAdam GreenAnna GriceSinéad KellyDaisy MackleVictor MarianoLinda ParkPauline SibleyWilliam SpencerElena BignamiValentina BelliniFrancesco ForforiMaria CurciAlessandra LeoMatthew JacksonJennifer AwolesiSheila HodgkinsonAlissa KentDee LeonardClaire StapletonClare TibkeFarhad Alexander-sefreLorraine CampeyKathryn HallJennifer SpimpoloMalin NilssonHelen DidrikssonEmma HamiltonMandy CarnahanChris MowattJo StickleyAntonio CorcioneGiuseppe RossiHege FladbyNina AndersenGunhild BjoernåMads ReiteLinda RoertveitPhilipp SeidelGlenn ArnoldMelissa BenaventeAnjalee ChattersinghNyasha ChirongaGillian HornzeeJoyce KibaruIhtisham MalikLaura McleavyByiravey PathmanathanFlorence PriorRhea StrudwickMarios VezyrgiannisAneeta SinhaSheeba BabuBisanth BatuwitageZoe DalyKatharine EllinorElizabeth HawesAnn HolmesKaren HudsonJeremy NightingaleAlison Le PoidevinLindsey RobertsAgnieszka Kubisz-pudelkoJoanna AllisonLucy PippardVincent HamlynAngie OrganAdanma Ezihe-ejioforThaventhran PrabhaharHayley BridgerLee DvorkinVitul ManhasRachel VincentShondipon LahaTerri-louise CromieDonna DoyleRachel HowarthMark VerlanderAilsa WattAlexandra WilliamsMassimo AntonelliSalvatore CutuliLuca MontiniJuan GraterolBenita AdamsSarah BeanKaren BurtFiona HammondsSuyogi JigajinniLaura FultonStephen KinghornJost MullenheimKirsty BaillieMartyn CainKerry CollingCarol HannawayRuggero CorsoMorena CalliCarlos FerrandoEsther RomeroPablo Jorge-monjasMaría Soria-garcíaJosé Gómez-herrerasRita Rodríguez-jiménezBlanca De Prada-martín

subject

Pulmonary and Respiratory Medicinemedicine.medical_treatmentPopulationNO03 medical and health sciences0302 clinical medicineCPAPAbdomenSettore MED/41 - ANESTESIOLOGIAIntubation IntratrachealmedicineHumansIntubation030212 general & internal medicineContinuous positive airway pressureAdverse effecteducationeducation.field_of_studyContinuous Positive Airway Pressurebusiness.industryrespiratory complications; continuous positive airway pressure; major abdominal surgeryPneumoniaMiddle Agedmedicine.diseaserespiratory tract diseasesIntratrachealPneumoniaTreatment Outcome030228 respiratory systemRespiratory failureAnesthesiaVomitingmedicine.symptomRespiratory InsufficiencyIntubationbusinessAbdominal surgery

description

BackgroundRespiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.MethodsPRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.FindingsBetween Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81-1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.InterpretationIn this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.FundingNational Institute for Health Research, Barts Charity, Intersurgical, Association of Anaesthetists, and Sapienza Università di Roma.

yearjournalcountryeditionlanguage
2021-11-01
http://hdl.handle.net/11573/1554967