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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

Background: Although widely applied, noninvasive ventilatory support (NIVS) efficacy in COVID-19 disease is unknown. Early identification of treatment failure is warranted to avoid delays in endotracheal intubation and protective ventilation. We conducted a study to determine the rate of and factors associated to NIVS failure in critically ill patients with COVID-19 disease, and to compare NIVS failure rate in COVID-19 patients to that of a matched cohort with hypoxemic respiratory failure of other origins. Methods: All consecutive patients receiving first-line treatment NIVS for hypoxemic respiratory failure due to COVID-19 in the ICU of a University Hospital in Italy up to April 20th, 2020, were studied: laboratory data were collected on arrival, 28-day outcome was recorded. After one-to-one propensity score matching based on simplified acute physiology (SAPS) II score, age, PaO2/FiO2 and PaCO2 at arrival, NIVS failure rate in COVID-19 patients was compared to a previously published cohort who received NIVS during hypoxemic respiratory failure from other causes. Results: Eighty-five patients received first-line treatment with NIVS, mainly with helmet noninvasive ventilation and high-flow nasal cannula. Fifty-two patients (61%) needed endotracheal intubation. Independent predictors of NIVS failure were SAPSII score (adjusted hazard ratio 1.039 [1.018-1.061], Conclusions: COVID-19 patients receiving first-line NIVS are burdened by high risk of needing endotracheal intubation: this appears greater than that of patients affected by hypoxemic respiratory failure of other origins. In order to not delay endotracheal intubation, if logistically sustainable, NIVS use in the intensive care unit should be avoided in severe patients (SAPSII score≥33) with serum lactate de-hydrogenase≥405 Units/Liter.

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.