11 research outputs found

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

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    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

    Safety of a training program for ultrasound-guided internal jugular vein catheterization in critically ill patients

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    OBJECTIVES: Evaluate the safety and effectiveness of a training program for performing ultrasound-guided internal jugular vein cannulation in critically ill patients. METHODS: Cohort prospective study, evaluating adult patients admitted in a teaching intensive care unit (ICU). Catheter placement was performed by an ICU medical resident. The patient's baseline characteristics, vessel's position and operator experience were the evaluated variables. The main outcomes were cannulation success rate and incidence of major complications. RESULTS: A total of 118 consecutive patients were enrolled between May 2008 and November 2009. The success rate of ultrasound guided catheter placement was 90% (106/118), 77% in the first attempt. Major complications occurred in 4% of the cases (n = 5) and were not associated with the analyzed variables. Inability to place the guide wire was the reason for 58% (7/12) of the failures. Operators with more than 15 previous ultrasound guided cannulations had an increased success rate (95% vs. 79%, p = 0.01) and increased failure was related to previous catheterization (26% vs. 7%, p = 0.02). CONCLUSION: Learning ultrasound guidance for IJV vein cannulation was safe and feasible in ICU patients. This process was not associated to complications and better results were achieved across the spectrum of operator experienc
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