Sigh in patients with acute hypoxemic respiratory failure and acute respiratory distress syndrome: the PROTECTION pilot randomized clinical trial

Cesare Gregoretti, Andrea Cortegiani, Egle Rondelli, Oriol Roca, Carla Fornari, Claude Guerin, Jian-Xin Zhou, Rocco D'Andrea, Jordi Mancebo, Tommaso Mauri, Huiqing Ge, Giacomo Grasselli, Roberto Rona, Savino Spadaro, Roberto Fumagalli, Tobias Becher, Federica Lovisari, Domenico Luca Grieco, Denise Battaglini, Eugenio GarofaloRiccardo Colombo, Mariana Luz, Ánxela Vidal González, Marco Ranieri, Dimitrios Bampalis, Tomas Jovaisa, Rihard Knafelj, Riccardo Pinciroli, Italo Calamai, Daniela Tubiolo, Vojka Gorjup, Paolo Navalesi, Carlo Alberto Volta, Giuseppe Foti, Jean-Michel Constantin, Antonio Pesenti, Paolo Pelosi, Laurent Brochard, Mariachiara Ippolito

Risultato della ricerca: Articlepeer review

2 Citazioni (Scopus)


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.
Lingua originaleEnglish
Numero di pagine27
Stato di pubblicazionePublished - 2020

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

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