Sigh in patients with acute hypoxemic respiratory failure and acute respiratory distress syndrome: the PROTECTION pilot randomized clinical trial
- Autori: Mauri, Tommaso; Foti, Giuseppe; Fornari, Carla; Grasselli, Giacomo; Pinciroli, Riccardo; Lovisari, Federica; Tubiolo, Daniela; Volta, Carlo Alberto; Spadaro, Savino; Rona, Roberto; Rondelli, Egle; Navalesi, Paolo; Garofalo, Eugenio; Knafelj, Rihard; Gorjup, Vojka; Colombo, Riccardo; Cortegiani, Andrea; Zhou, Jian-Xin; D'Andrea, Rocco; Calamai, Italo; González, Ánxela Vidal; Roca, Oriol; Grieco, Domenico Luca; Jovaisa, Tomas; Bampalis, Dimitrios; Becher, Tobias; Battaglini, Denise; Ge, Huiqing; Luz, Mariana; Constantin, Jean-Michel; Ranieri, Marco; Guerin, Claude; Mancebo, Jordi; Pelosi, Paolo; Fumagalli, Roberto; Brochard, Laurent; Pesenti, Antonio; PROTECTION collaborators: Alessandra Papoff, Raffaele Di Fenza, Stefano Gianni, Elena Spinelli, Alfredo Lissoni, Chiara Abbruzzese, Alfio Bronco, Silvia Villa, Vincenzo Russotto, Arianna Iachi, Lorenzo Ball, Nicolò Patroniti, Rosario Spina, Romano Giuntini, Simone Peruzzi, Luca Salvatore Menga, Tommaso Fossali, Antonio Castelli, Davide Ottolina, Marina García-de-Acilu, Manel Santafè, Dirk Schädler, Norbert Weiler, Emilia Rosas Carvajal, César Pérez Calvo, Evangelia Neou, Yu-Mei Wang, Yi-Min Zhou, Federico Longhini, Andrea Bruni, Mariacristina Leonardi, Cesare Gregoretti, Mariachiara Ippolito, Zelia Milazzo, Lorenzo Querci, Serena Ranieri, Giulia Insom, Jernej Berden, Marko Noc, Ursa Mikuz, Matteo Arzenton, Marta Lazzeri, Arianna Villa, Bruna Brandão Barreto, Marcos Nogueira Oliveira Rios, Dimitri Gusmao-Flores, Mandeep Phull, Tom Barnes, Hussain Musarat, Sara Conti
- Anno di pubblicazione: 2020
- Tipologia: Articolo in rivista
- OA Link: http://hdl.handle.net/10447/443882
Abstract
Background: Sigh is a cyclic brief recruitment manoeuvre: previous physiological 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 multi-center non-inferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or acute respiratory distress syndrome 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 of airway pressure to 30 cmH2Ofor 3 seconds once per minute) until day 28 or death or successful spontaneous breathing trial. The primary endpoint of the study was feasibility, assessed as non-inferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiological parameters in the first week from randomization, 28-day mortality and ventilator-free days. Results: Two-hundred 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=0.015 for non-inferiority). Adverse events occurred in 12% vs. 13% in Sigh vs. No Sigh (p=0.852). Oxygenation was improved while tidal volume, respiratory rate and corrected minute ventilation were lower over the first 7 days from randomization in Sigh vs. No Sigh. There was no significant difference in terms of mortality (16% vs. 21%, p=0.342) and ventilator-free days (22 [7-26] vs. 22 [3-25] days, p=0.300) for Sigh vs. No Sigh. Interpretation: Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.