Pressure support ventilation plus sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial
Por:
Mauri, T, Foti, G, Fornari, C, Constantin, JM, Guerin, C, Pelosi, P, Ranieri, M, Conti, S, Tubiolo, D, Rondelli, E, Lovisari, F, Fossali, T, Spadaro, S, Grieco, DL, Navalesi, P, Calamai, I, Becher, T, Roca, O, Wang, YM, Knafelj, R, Cortegiani, A, Mancebo, J, Brochard, L, Pesenti, A, Protection Study Grp
Publicada:
29 ago 2018
Resumen:
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 cmH(2)O. 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.
Filiaciones:
Mauri, T:
Univ Milan, Fdn IRCCS Ca Granda Osped Maggiore Policlin, Milan, Italy
Foti, G:
Univ Milano Bicocca, ASST Monza, Monza, Italy
Fornari, C:
Univ Milano Bicocca, Sch Med & Surg, Res Ctr Publ Hlth, Monza, Italy
Constantin, JM:
Univ Hosp Clermont Ferrand, Dept Preoperat Med, Clermont Ferrand, France
Guerin, C:
Hop Croix Rousse, Serv Reanimat Med, Lyon, France
Pelosi, P:
Univ Genoa, IRCCS Oncol, San Martino Policlin Hosp, Dept Surg & Integrated Diagnost, Genoa, Italy
Ranieri, M:
Sapienza Univ Rome, Dept Anesthesia & Intens Care Med, Policlin Umberto 1, Rome, Italy
Conti, S:
Univ Milano Bicocca, Sch Med & Surg, Res Ctr Publ Hlth, Monza, Italy
Rondelli, E:
Univ Milano Bicocca, ASST Monza, Monza, Italy
Lovisari, F:
Univ Milano Bicocca, Niguarda Hosp, Dept Anesthesia & Crit Care, Milan, Italy
Fossali, T:
Luigi Sacco Hosp, Dept Anesthesiol & Intens Care, ASST Fatebenefratelli Sacco, Milan, Italy
Spadaro, S:
Univ Arcispedale St Anna, Azienda Osped, Dept Morphol Surg & Expt Med, Ferrara, Italy
Grieco, DL:
Univ Cattolica Sacro Cuore, IRCCS Fdn Policlin A Gemelli, Dept Anesthesiol & Intens Care Med, Rome, Italy
Navalesi, P:
Magna Graecia Univ Catanzaro, Azienda Osped Univ Mater Domini, Dipartimento Sci Med & Chirurg, Catanzaro, Italy
Calamai, I:
San Giuseppe Hosp, Unit Anesthesia & Resuscitat, AUSL Toscana Ctr, Empoli, Italy
Becher, T:
Univ Med Ctr Schleswig Holstein, Dept Anesthesiol & Intens Care Med, Campus Kiel, Kiel, Germany
Roca, O:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Vall dHebron Res Inst, Crit Care Dept, Barcelona, Spain
Wang, YM:
Capital Med Univ, Beijing Tiantan Hosp, Dept Crit Care Med, Beijing, Peoples R China
Cortegiani, A:
Univ Palermo, Dept Biopathol & Med Biotechnol DIBIMED, Sect Anesthesia Analgesia Intens Care & Emergency, Policlin Paolo Giaccone, Palermo, Italy
Mancebo, J:
UAB, Hosp Santa Creu & Sant Pau, Serv Med Intensiva, Barcelona, Spain
Brochard, L:
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr, Toronto, ON, Canada
Pesenti, A:
Univ Milan, Fdn IRCCS Ca Granda Osped Maggiore Policlin, Milan, Italy
Univ Milan, Dept Pathophysiol & Transplantat, Anesthesia & Crit Care, Milan, Italy
Fdn IRCCS Ca Granda Osped Maggiore Policlin, Dept Anesthesia Crit Care & Emergency, Via F Sforza 35, I-20122 Milan, Italy
Larissa Gen Hosp, Intens Care Unit, Larisa, Greece.
Hosp Univ Fdn Jimenez Diaz Madrid, Madrid, Spain.
BHR Univ Hosp NHS Trust, Romford, Greater London, England.
Sud Ile De France Hosp, Dept Intens Care Med, Melun, France.
Univ Angers, CHU Angers, Dept Med Intens Reanimat, Angers, France.
Univ Hosp St Orsola Malpighi, Dept Anesthesiol Intens Care & Transplants, Bologna, Italy.
Ist Clin Humanitas, Milan, Italy.
Univ Med Ctr Ljubljana, Ctr Internal Intens Med MICU, Ljubljana, Slovenia.
Gold, Green Published
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