Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS The PROTECTION Pilot Randomized Clinical Trial
Por:
Mauri, T, Foti, G, Fornari, C, Grasselli, G, Pinciroli, R, Lovisari, F, Tubiolo, D, Volta, CA, Spadaro, S, Rona, R, Rondelli, E, Navalesi, P, Garofalo, E, Knafelj, R, Gorjup, V, Colombo, R, Cortegiani, A, Zhou, JX, D'Andrea, R, Calamai, I, Gonzalez, AV, Roca, O, Grieco, DL, Jovaisa, T, Bampalis, D, Becher, T, Battaglini, D, Ge, HQ, Luz, M, Constantin, JM, Ranieri, M, Guerin, C, Mancebo, J, Pelosi, P, Fumagalli, R, Brochard, L, Pesenti, A
Publicada:
1 abr 2021
Ahead of Print:
1 abr 2021
Resumen:
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.
Filiaciones:
Mauri, T:
Univ Milan, Dept Pathophysiol & Transplantat, Milan, Italy
Fdn IRCCS Ca Granda Maggiore Policlin Hosp, Dept Anesthesia Crit Care & Emergency, Milan, Italy
Foti, G:
ASST Monza, San Gerardo Hosp, Anesthesia & Crit Care, Monza, Italy
Univ Milano Bicocca, Sch Med & Surg, Monza, Italy
Fornari, C:
Univ Milano Bicocca, Sch Med & Surg, Monza, Italy
Grasselli, G:
Univ Milan, Dept Pathophysiol & Transplantat, Milan, Italy
Fdn IRCCS Ca Granda Maggiore Policlin Hosp, Dept Anesthesia Crit Care & Emergency, Milan, Italy
Pinciroli, R:
Univ Milano Bicocca, Sch Med & Surg, Monza, Italy
Osped Niguarda Ca Granda, Anesthesia & Crit Care Serv 1, Milan, Italy
Lovisari, F:
Osped Niguarda Ca Granda, Anesthesia & Crit Care Serv 1, Milan, Italy
Tubiolo, D:
Fdn IRCCS Ca Granda Maggiore Policlin Hosp, Dept Anesthesia Crit Care & Emergency, Milan, Italy
Volta, CA:
Univ Ferrara, Morphol Surg & Expt Med, Anesthesia & Intens Care Unit, Ferrara, Italy
Spadaro, S:
Univ Ferrara, Morphol Surg & Expt Med, Anesthesia & Intens Care Unit, Ferrara, Italy
Rona, R:
ASST Monza, San Gerardo Hosp, Anesthesia & Crit Care, Monza, Italy
Rondelli, E:
ASST Monza, San Gerardo Hosp, Anesthesia & Crit Care, Monza, Italy
Navalesi, P:
Univ Padua, Dept Med DIMED, Padua, Italy
Padua Hosp, Inst Anesthesia & Intens Care, Padua, Italy
Garofalo, E:
Magna Graecia Univ Catanzaro, Dept Med & Surg Sci, Anesthesia & Intens Care, Catanzaro, Italy
Knafelj, R:
Univ Med Ctr Ljubljana, Ctr Internal Intens Med, Ljubljana, Slovenia
Gorjup, V:
Univ Med Ctr Ljubljana, Ctr Internal Intens Med, Ljubljana, Slovenia
Colombo, R:
ASST Fatebenefratelli Sacco, Dept Anesthesiol & Intens Care, Milan, Italy
Cortegiani, A:
Univ Palermo, Sect Anesthesia Analgesia Intens Care & Emergency, Dept Surg Ontol & Oral Sci, Policlin Paolo Giaccone, Palermo, Italy
Zhou, JX:
Capital Med Univ, Beijing Tiantan Hosp, Dept Crit Care Med, Beijing, Peoples R China
D'Andrea, R:
Univ Hosp St Orsola Malpighi, Dept Anesthesiol Intens Care & Transplants, Bologna, Italy
Calamai, I:
San Giuseppe Hosp, AUSL Toscana Ctr, Unit Anesthesia & Resuscitat, Empoli, Italy
Gonzalez, AV:
Hosp Univ Fdn Jimenez Diaz Madrid, Madrid, Spain
Roca, O:
Univ Autonoma Barcelona, Crit Care Dept, Vall dHebron Univ Hosp, Vall dHebron Res Inst, Barcelona, Spain
Inst Salud Carlos III, CIBER Enfermedades Resp CIBERES, Madrid, Spain
Grieco, DL:
Univ Cattolica Sacro Cuore, IRCCS Fdn Policlin A Gemelli, Dept Anesthesiol & Intens Care Med, Rome, Italy
Jovaisa, T:
Barking Havering & Redbridge Univ Hosp NHS Trust, Crit Care Serv, Anaesthet Div, London, England
Bampalis, D:
Larissa Gen Hosp, Intens Care Unit, Larisa, Greece
Becher, T:
Univ Klinikum Schleswig Holstein, Klin Anasthesiol & Operat Intens Med, Campus Kiel, Kiel, Germany
Battaglini, D:
Univ Genoa, Dept Surg Sci & Integrated Diagnost, Genoa, Italy
San Martino Policlin Hosp, IRCCS Oncol & Neurosci, Anesthesia & Intens Care, Genoa, Italy
Ge, HQ:
Zhejiang Univ, Sch Med, Sir Run Run Shaw Hosp, Hangzhou, Peoples R China
Luz, M:
Hosp Mulher, Intens Care Dept, Salvador, BA, Brazil
Univ Fed Bahia, Hosp Univ Prof Edgard Santos, Intens Care Dept, Salvador, BA, Brazil
Constantin, JM:
Sorbonne Univ, Pitie Salpetriere Hosp, AP HP, DMU DREAM,Dept Anesthesiol & Crit Care,GRC 29, Paris, France
Ranieri, M:
Univ Hosp St Orsola Malpighi, Dept Anesthesiol Intens Care & Transplants, Bologna, Italy
Guerin, C:
Univ Lyon, Fac Med Lyon Est, Med Intens Reanimat Grp Hosp Edouard Herriot, Lyon, France
Mancebo, J:
Univ Autonoma Barcelona UAB, Hosp Santa Creu & St Pau, Serv Med Intens, Barcelona, Spain
Pelosi, P:
Univ Genoa, Dept Surg Sci & Integrated Diagnost, Genoa, Italy
San Martino Policlin Hosp, IRCCS Oncol & Neurosci, Anesthesia & Intens Care, Genoa, Italy
Fumagalli, R:
Univ Milano Bicocca, Sch Med & Surg, Monza, Italy
Osped Niguarda Ca Granda, Anesthesia & Crit Care Serv 1, Milan, Italy
Brochard, L:
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Pesenti, A:
Univ Milan, Dept Pathophysiol & Transplantat, Milan, Italy
Fdn IRCCS Ca Granda Maggiore Policlin Hosp, Dept Anesthesia Crit Care & Emergency, Milan, Italy
hybrid, Green Published
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