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

Correlation of clinical features with the risk of lower limb deep vein thrombosis assessed by duplex ultrasound

BACKGROUND: Symptoms and clinical signs suggestive of deep vein thrombosis (DVT) are common but may have numerous possible causes. OBJECTIVES: 1) To identify the most frequent clinical symptoms and correlate them with duplex ultrasound scan (DS) findings; 2) to identify high-risk clinical conditions for DVT; and 3) to evaluate time since the onset of symptoms and DS examination. METHODS: A total of 528 patients with a clinical suspicion of DVT were evaluated by DS performed by experienced vascular ultrasonographists. RESULTS: DVT was present in 192 (36.4%) of the patients. The external iliac vein was involved in 53 patients (10.04%), the femoral veins in 110 (20.83%), the popliteal vein in 124 (23.48%), and veins below the knee were involved in 157 (29.73%) of the cases. Limb swelling was present in 359 cases (68%), and 303 (57.4%) complained of pain. Sixty nine patients received a DS due to suspected or proven pulmonary embolism (PE); 79 patients were in postoperative period. In the multivariate analysis, independent risk factors for DVT included age>65 years (OR=1.49; 95% confidence interval [95%CI] 1.01-2.18; p=0.042), edema (OR=2.83; 95%CI 1.72-4.65; p<0.001), pain (OR=1.99; 95%CI 1.3-3.05; p=0.002), cancer (OR=2.32; 95%CI 1.45-3.72; p<0.001), and PE (OR=2.62; 95%CI 1.29-5.32; p=0.008).Time since the onset of symptoms did not differ between the groups. CONCLUSIONS: In the present study, 36.4% of the patients referred to DS had DVT. Age > 65 years, presence of limb swelling, pain, cancer, and suspected or proven PE should be considered as major risk factors for DVT

Evaluation with Doppler vascular ultrasound in postoperative endovascular treatment of abdominal aortic aneurysm: a prospective comparative study with angiotomography

BACKGROUND: Diagnosis of abdominal aortic aneurysm (AAA) is usually incidental, and surgical treatment, when indicated, may be open or endovascular. The drawbacks of computed angiotomography (CTA) and the advantages of Doppler ultrasonography have led to the development of alternative follow-up protocols, comparing the two methods. OBJECTIVE: To determine validity indices for Doppler ultrasonography and to correlate them with CTA results in a group of patients who had undergone elective endovascular treatment of AAAs. MATERIAL AND METHODS: Thirty-three patients were selected. The following three items were evaluated: 1) presence or absence of endoleak; 2) presence of blood flow in the aortoiliac segment; and 3) maximum AAA diameter. RESULTS: For the detection of endoleak, Doppler ultrasonography showed a sensitivity of 54.5%, a specificity of 92.8%, a positive predictive value of 85.7%, a negative predictive value of 92.8%, and an overall accuracy of 76%. For the evaluation of blood flow in the aortoiliac segment, values were 100, 97.8, 80, 97.8, and 98%, respectively. Maximum AAA diameter was similarly measured by both methods, with statistically significant differences (mean difference: 1.98 mm). Pearson's correlation coefficient was 0.97, showing that Doppler ultrasonography and CTA yielded similar results. CONCLUSION: Doppler ultrasonography showed good validity indices and a moderate correlation with CTA in the postoperative evaluation of patients undergoing endovascular treatment of AAAs

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