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RESEARCH PRODUCT
Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: Study protocol for a pilot randomized controlled trial, the PROTECTION trial
Tommaso MauriGiuseppe FotiCarla FornariJean-michel ConstantinClaude GuerinPaolo Pasqualino PelosiMarco RanieriSara ContiDaniela TubioloEgle RondelliFederica LovisariTommaso FossaliSavino SpadaroDomenico Luca GriecoPaolo NavalesiItalo CalamaiTobias BecherOriol RocaYu-mei WangRihard KnafeljAndrea CortegianiJordi ManceboLaurent BrochardAntonio PesentiGiacomo GrasselliElena SpinelliChiara AbbruzzeseRoberto RonaAlfio BroncoSilvia VillaStefano GianniAlessandra PapoffRiccardo PinciroliRiccardo ColomboChiara SproccatiPietro MandelliFederico VillaNicolo' PatronitiIole BrunettiLorenzo BallCarlo Alberto VoltaMarta LazzeriElisabetta MaragoniDavide EleuteriGiuseppe BelloAntonio Dell'annaEugenio GarofaloAndrea BruniEugenio BiamonteRocco D'andreaLorenzo QuerciElisabetta PierucciRosario SpinaIrene MoriFrancesco TomeoAlain MercatFrançois BeloncleSebastien JochmansSandie MazerandLoredana BaboiHodane YonisMatthieu JabaudonThomas GodetTomas JovaisaTom BarnesUsman TariqNorbert WeilerDirk SchädlerInéz FrerichsMarina García-de-aciluAnxela VidalEmilia RosasCésar Pérez CalvoJian-xin ZhouSpiridon KaragiannisVasiliki ZisopoulouIoannis StaikosMarko NocMisa FisterPeter RadselCesare GregorettiIgnazio SabellaSanti Maurizio Rainerisubject
procedurePressure supportTime Factorsgenetic structuresbreathingmedicine.medical_treatmentMedicine (miscellaneous)Pilot Projects[SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tractintensive care unitlaw.inventionPositive-Pressure RespirationStudy Protocol0302 clinical medicineMechanical ventilationRandomized controlled triallawtime factorClinical endpointpatient safetyMulticenter Studies as TopicPharmacology (medical)030212 general & internal medicinerandomized controlled trial (topic)Intervention study; Mechanical ventilation; Positive-pressure ventilation; Pressure support; Recruitment; Sigh; Ventilator-induced lung injury; Weaning; Feasibility Studies; Humans; Hypoxia; Intubation Intratracheal; Lung; Multicenter Studies as Topic; Pilot Projects; Positive-Pressure Respiration; Recovery of Function; Respiratory Insufficiency; Time Factors; Treatment Outcome; Randomized Controlled Trials as Topic; Medicine (miscellaneous); Pharmacology (medical)HypoxiaLungpathophysiologyendotracheal intubationRandomized Controlled Trials as TopicVentilator-induced lung injurylcsh:R5-920Intervention studyadultpilot studyfeasibility studytreatment outcome Feasibility Studie3. Good healthTreatment OutcomeAnesthesiapositive end expiratory pressureBreathingmulticenter study (topic)oxygenationRecruitmentlcsh:Medicine (General)Respiratory Insufficiencyrespiratory tract intubationcirculatory and respiratory physiologyHumanextubationPressure support ventilationWeaningLung injuryArticleSpontaneous breathing trialNO03 medical and health sciencesIntensive care[SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO]medicineIntubation IntratrachealHumanscontrolled studyPilot ProjectSightreatment failureMechanical ventilationhypoxemiapressure support ventilationtreatment durationbusiness.industrylung inflationrespiratory failureconvalescenceRecovery of Functionmajor clinical studymortalitywater acute respiratory failurehospital dischargeIntratracheal030228 respiratory systemrandomized controlled trialFeasibility StudiesbusinessPositive-pressure ventilationIntubationclinical protocoldescription
Background Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH2O. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22%). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80% and first-risk order to 5%, the computed size of the trial is 129 patients per arm. Discussion PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days. Trial registration ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-2828-8) contains supplementary material, which is available to authorized users.
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2018-08-01 |