6533b826fe1ef96bd12844cd

RESEARCH PRODUCT

Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS

Tommaso MauriGiuseppe FotiCarla FornariGiacomo GrasselliRiccardo PinciroliFederica LovisariDaniela TubioloCarlo Alberto VoltaSavino SpadaroRoberto RonaEgle RondelliPaolo NavalesiEugenio GarofaloRihard KnafeljVojka GorjupRiccardo ColomboAndrea CortegianiJian-xin ZhouRocco D’andreaItalo CalamaiÁNxela Vidal GonzálezOriol RocaDomenico Luca GriecoTomas JovaisaDimitrios BampalisTobias BecherDenise BattagliniHuiqing GeMariana LuzJean-michel ConstantinMarco RanieriClaude GuerinJordi ManceboPaolo PelosiRoberto FumagalliLaurent BrochardAntonio PesentiNull Plug Working Group Of EsicmAlessandra PapoffRaffaele Di FenzaStefano GianniElena SpinelliAlfredo LissoniChiara AbbruzzeseAlfio BroncoSilvia VillaVincenzo RussottoArianna IachiLorenzo BallNicolò PatronitiRosario SpinaRomano GiuntiniSimone PeruzziLuca Salvatore MengaTommaso FossaliAntonio CastelliDavide OttolinaMarina García-de-aciluManel SantafèDirk SchädlerNorbert WeilerEmilia Rosas CarvajalCésar Pérez CalvoEvangelia NeouYu-mei WangYi-min ZhouFederico LonghiniAndrea BruniMariacristina LeonardiCesare GregorettiMariachiara IppolitoZelia MilazzoLorenzo QuerciSerena RanieriGiulia InsomJernej BerdenMarko NocUrsa MikuzMatteo ArzentonMarta LazzeriArianna VillaBruna Brandão BarretoMarcos Nogueira Oliveira RiosDimitri Gusmao-floresMandeep PhullTom BarnesHussain MusaratSara Conti

subject

Pulmonary and Respiratory MedicineARDSbusiness.industryPressure support ventilationCritical Care and Intensive Care Medicinemedicine.diseaseSpontaneous breathing triallaw.invention03 medical and health sciences0302 clinical medicine030228 respiratory systemRandomized controlled triallawAnesthesiaBreathingMedicine030212 general & internal medicineCardiology and Cardiovascular MedicinebusinessRespiratory minute volumePositive end-expiratory pressureTidal volume

description

Background Sigh is a cyclic brief recruitment maneuver: previous physiologic studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity, and increase release of surfactant. Research Question Is the clinical application of sigh during pressure support ventilation (PSV) feasible? Study Design and Methods We conducted a multicenter noninferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or ARDS undergoing PSV. Patients were randomized to the no-sigh group and treated by PSV alone, or to the sigh group, treated by PSV plus sigh (increase in airway pressure to 30 cm H2O for 3 s once per minute) until day 28 or death or successful spontaneous breathing trial. The primary end point of the study was feasibility, assessed as noninferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiologic parameters in the first week from randomization, 28-day mortality, and ventilator-free days. Results Two-hundred and fifty-eight patients (31% women; median age, 65 [54-75] years) were enrolled. In the sigh group, 23% of patients failed to remain on assisted ventilation vs 30% in the no-sigh group (absolute difference, –7%; 95% CI, –18% to 4%; P = .015 for noninferiority). Adverse events occurred in 12% vs 13% in the sigh vs no-sigh group (P = .852). Oxygenation was improved whereas tidal volume, respiratory rate, and corrected minute ventilation were lower over the first 7 days from randomization in the sigh vs no-sigh group. There was no significant difference in terms of mortality (16% vs 21%; P = .337) and ventilator-free days (22 [7-26] vs 22 [3-25] days; P = .300) for the sigh vs no-sigh group. Interpretation Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk. Trial Registry ClinicalTrials.gov ; No.: NCT03201263 ; URL: www.clinicaltrials.gov

https://doi.org/10.1016/j.chest.2020.10.079