Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

The Impact of Body Mass Index in Patients with Severe Burn Injury

This study evaluated the association of body mass index (BMI) with mortality, length of stay in the intensive care unit (ICU), and length of hospital stay in major burn patients. It was a retrospective cohort study that was originally conducted from January 2017 to January 2020 and that used data from patients admitted to the intensive care unit for burns at a university hospital. The patients were divided into groups for the purposes of comparing relevant variables according to their BMI. We evaluated 288 patients: 52.8% were classified as eutrophic, 33.7% were classified as overweight, and 13.5% were classified as obese. The median length of stay in the ICU was 11 days for all patients, 9 days for eutrophic patients, 13 days for overweight patients, and 16 days for obese patients (p = 0.004). In the multivariate analysis, age (HR = 1.026; p < 0.001), total body surface area (HR = 1.047; p < 0.001), and the presence of inhalation injury (HR = 1.658; p = 0.026) were associated with mortality. Obesity was not associated with higher hospital mortality in this sample of burn patients. The length of stay in the ICU was longer among obese patients. Age, burned body surface, and the presence of inhalation injury were the major determinants of death in these patients

Improved performance of an intensive care unit after changing the admission triage model

Abstract The aim of this study is to analyze the effect of implementing a prioritization triage model for admission to an intensive care unit on the outcome of critically ill patients. Retrospective longitudinal study of adult patients admitted to the Intensive Care Unit (ICU) carried out from January 2013 to December 2017. The primary outcome considered was vital status at hospital discharge. Patients were divided into period 1 (chronological triage) during the years 2013 and 2014 and period 2 (prioritization triage) during the years 2015–2017. A total of 1227 patients in period 1 and 2056 in period 2 were analyzed. Patients admitted in period 2 were older (59.8 years) compared to period 1 (57.3 years; p < 0.001) with less chronic diseases (13.6% vs. 19.2%; p = 0.001), and higher median APACHE II score (21.0 vs. 18.0; p < 0.001)) and TISS 28 score (28.0 vs. 27.0; p < 0.001). In period 2, patients tended to stay in the ICU for a shorter time (8.5 ± 11.8 days) compared to period 1 (9.6 ± 16.0 days; p = 0.060) and had lower mortality at ICU (32.8% vs. 36.9%; p = 0.016) and hospital discharge (44.2% vs. 47.8%; p = 0.041). The change in the triage model from a chronological model to a prioritization model resulted in improvement in the performance of the ICU and reduction in the hospital mortality rate

Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.13Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt