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RESEARCH PRODUCT

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

T. BluthR. TeichmannM. HiesmayrTania SocorroAna IzquierdoMarina SoroManuel Granell GilMaría José Hernández CádizElena Biosca PérezAlejandro Suarez-de-la-ricaMercedes Lopez-martinezIván HuercioEmilio MasedaM. W. HollmannJulio YagüeAlba Cebrian MorenoEva RivasManuel Lopez-baamondeHamed ElgendyMohamed SayedalahlAbdul Razak SiibaiAysen YavruNukhet SivrikozMeltem KaradenizS. JaberPelin Corman DincerHilmi Omer AyanogluGulbin Tore AltunAyse Duygu KavasBora DincBahar KuvakiSule OzbilginDilek ErdoganCeren KoksalSuheyla AbitagagluJ. G. LaffeyCaterina AurilioPasquale SansoneCaterina Maria PaceValerio DonatielloSilvana MatteraPalange NazarenoSalvatore Di ColandreaSavino SpadaroCarlo Alberto VoltaRiccardo RagazziM. J. LickerStefano CiardoLuca GobbiPaolo SevergniniAlessandro BacuzziElisa BrugnoniAngelo GratarolaCamilla MicalizziFrancesca SimonassiPatrizia MalerbiAdrea CarboniK. MarkstallerMarc-joseph LickerAlexander DullenkopfNicolai GoettelVisnja Nesek AdamMaja Karaman IlicVlasta KlaricBibiana VitkovicMorena MilicMiro ZupcicLuc De BaerdemaekerI. MatotStefan De HertBjorn HeyseJurgen Van LimmenYves Van NieuwenhoveEls MertensArne NeyrinckJan MulierDavid KahnDaniela GodorojaMartin Martin-loechesG. MüllerSergiy VorotyntsevValentyna FronchkoIdit MatotOr GorenLilach ZacThomasz GaszynskiJon LaffeyGary H MillsPramod NalwayaMark Mac GregorG. H. MillsJonathan PaddlePackianathaswamy BalajiFrancesca RubulottaAfeez AdebesinMike MargarsonSimon DaviesDesikan RangarajanChristopher NewellMirjana ShosholchevaFotios PapaspyrosJ. P. MulierVasiliki SkandalouPaula DzurnakovT. KissC. PutensenRolf RossaintJ. SchmittM. SenturkA. Serpa NetoP. SevergniniJ. SprungM. F. Vidal MeloH. WriggeM. J. SchultzI. BobekP. PelosiM. Gama De AbreuProbese InvestigatorsProtective Ventilation Network (Provenet)Clinical Trial Network Of The European Society Of Anaesthesiology (Esa)Andreas GüldnerRobert HuhleChristopher UhligLuigi VivonaAlice BergamaschiJ. CanetRolf RossaintAna StevanovicTanja TreschanMaximilian SchaeferPeter KienbaumRita Laufenberg-feldmannLars BergmannFelix EbnerLuisa RobitzkyPatrick MöldersG. CinnellaMatthias UnterbergCornelius BuschMarc AchillesAngelika MenzenHarbert FreesemannChristian PutensenHumberto MachadoCarla CavaleiroCristina FerreiraDaniela PinhoL. De BaerdemaekerMarta CarvalhoSílvia PinhoMaria SoaresDiogo Sousa CastroFernando AbelhaRui RabicoEllise DelphinJuraj SprungToby N. WeingartenTodd A. KelloggC. GregorettiYvette N. MartinTravis J. MckenzieSorin J. BrullJ. Ross RenewHarish RamakrishnaAna Fernandez-bustamanteKonstantin BalonovHarris R. BaigAalok KachaJuan C. PedemonteG. HedenstiernaFernando AltermattMarcia A. CorvettoSebastian ParedesJaviera CarmonaAugusto RolleElke BosCharlotte BeurskensB. VeeringHarry ZonneveldtChrista BoerS. N. HemmesMarc GodfriedBram ThielBarbara KabonChristian ReitererJaume CanetRaquel TolósMar SendraMiriam GonzálezNoemí GómezCarlos Ferrando

subject

MaleLung DiseasesTime Factors[SDV]Life Sciences [q-bio]Respiratory Medicine and Allergymedicine.medical_treatmentRESPIRATORY-DISTRESS-SYNDROMEMedicine (miscellaneous)HemodynamicsMechanical ventilation; Obesity; Positive end-expiratory pressure; Postoperative pulmonary complication; Recruitment maneuver; Medicine (miscellaneous); Pharmacology (medical)LAPAROSCOPIC BARIATRIC SURGERYLung DiseaseBody Mass Indexlaw.inventionPositive-Pressure RespirationStudy Protocol0302 clinical medicineMechanical ventilationClinical ProtocolsRandomized controlled trialRisk Factors030202 anesthesiologylawMedicine and Health SciencesClinical endpointAnesthesiaPharmacology (medical)Respiratory function030212 general & internal medicineLungLungmedicin och allergi2. Zero hungerlcsh:R5-920ddc:617Positive end-expiratory pressurerespiratory systemOperative3. Good healthTreatment OutcomeRecruitment maneuverTIDAL VOLUMESResearch DesignMechanical ventilation Positive end-expiratory pressure Recruitment maneuver Obesity Postoperative pulmonary complicationSurgical Procedures OperativeAnesthesiaBreathingFemaleErratumlcsh:Medicine (General)ALVEOLAR RECRUITMENT MANEUVERHumancirculatory and respiratory physiologymedicine.medical_specialtyTime FactorMechanical ventilation ; Obesity ; Positive end-expiratory pressure ; Postoperative pulmonary complication ; Recruitment maneuverAnesthesia GeneralLung injuryMechanical ventilation; Obesity; Positive end-expiratory pressure; Postoperative pulmonary complication; Recruitment maneuver; Body Mass Index; Clinical Protocols; Female; Humans; Intraoperative Care; Lung; Lung Diseases; Male; Obesity; Positive-Pressure Respiration; Protective Factors; Research Design; Risk Factors; Time Factors; Treatment Outcome; Anesthesia General; Surgical Procedures Operative; Medicine (miscellaneous); Pharmacology (medical)NOGENERAL-ANESTHESIADRIVING PRESSURE03 medical and health sciencesmedicineHumansddc:610ObesityClinical ProtocolGeneralProtective FactorPositive end-expiratory pressurePOSTOPERATIVE PULMONARY COMPLICATIONSMechanical ventilationSurgical ProceduresIntraoperative CareINTERNATIONAL CONSENSUSbusiness.industryRisk FactorProtective FactorsSurgeryMechanical ventilation; Obesity; Positive end-expiratory pressure; Postoperative pulmonary complication; Recruitment maneuverrespiratory tract diseasesbusinessPostoperative pulmonary complicationLUNG INJURY

description

Background Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. Methods/design The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. Discussion To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs. Trial registration ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1929-0) contains supplementary material, which is available to authorized users.

yearjournalcountryeditionlanguage
2017-04-01
10.1186/s13063-017-1929-0https://archive-ouverte.unige.ch/unige:99158