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

Le malattie professionali da radiazioni ottiche artificiali (ROA)

Introduzione: Con l\u2019entrata in vigore delle disposizioni di cui al Capo V del Titolo VIII del D.Lgs. 81/08 viene ad essere garantita dal legislatore la piena tutela della sicurezza e della salute dei lavoratori esposti a radiazioni ottiche artificiali (ROA). Obiettivi e metodi: Gli autori prendono in esame, sulla base dei dati della letteratura sull\u2019argomento, gli effetti sulla salute conseguenti all\u2019esposizione occupazionale a ROA. Risultati: Le patologie croniche correlate con esposizione a ROA nel range dello spettro fra 220 e 310 nm (UV) sono rappresentate da congiuntiviti e cheratocongiuntiviti croniche. Le patologie oncologiche della cute correlabili con l\u2019esposizione a RUV sono rappresentate dai carcinomi cutanei basocellulari e spinocellulari e dai melanomi cutanei. L\u2019effetto biologico delle radiazioni ottiche infrarosse (lunghezza d\u2019onda compresa fra 780 nm e 1 mm) \ue8 essenzialmente di natura termica. L\u2019esposizione a luce blu (lunghezza d\u2019onda compresa fra 380 e 550 nm) causa danni esclusivamente retinici ed \ue8 considerata responsabile dello sviluppo di quadri di Degenerazione Maculare Senile (AMD). Pur in presenza di dati sperimentali di laboratorio, non esistono tuttavia al momento dati epidemiologici che documentino i danni retinici da luce blu. Conclusioni: Nello studio vengono illustrati i criteri medico-legali per lo studio del nesso di causalit\ue0 fra esposizione professionale a ROA e danno, nonch\ue9 la metodologia e i momenti procedurali necessari per l\u2019iter valutativo. Vengono quindi presi in esame gli elenchi delle malattie professionali attribuite all\u2019esposizione a ROA presenti nel DM9 aprile 2008 e nel DM13 dicembre 2009. Infine gli autori propongono, sulla base di Linee Guida e dati della letteratura scientifica sull\u2019argomento, protocolli di sorveglianza sanitaria per la tutela della salute dei lavoratori esposti al rischio specifico.\uabOccupational diseases caused by artificial optical radiations (AOR)\ubb. Background: Italian national legislation guarantees safety and health for workers exposed to Artificial Optical Radiations (AOR) by Legislative Decree 81/2008. Objectives and methods: Effects and damages to health resulting from AOR exposure were analyzed from literature data. Results: Ultraviolet Radiations (UV), particularly those in the wavelength range between 220 and 310 nm, causes chronic conjunctivitis and kerato-conjunctivitis. Skin cancer caused by UV exposure included Basal Cell Carcinoma, Squamous Cell Carcinoma and Melanoma. As regards Infrared Radiations (portion of the spectrum between 780 nm and 1 mm), the biological effect is essentially of thermal nature. Exposure to Blue Light (portion of the spectrum of visible light radiation in a wavelength range between 380 and 550 nm) causes exclusively retinal damage and is considered to be responsible for the development of situations of Age-relatedMacular Degeneration (AMD). Even if experimental data are available, at the present time there is still no epidemiological evidence of retinal damage caused by blue light. Conclusions: The forensic criteria for investigating the causality link between occupational exposure to AOR and damage, and the methodology necessary for the assessment process, are reported.Two lists of occupational diseases which were included in the ItalianMinisterial Decrees, issued respectively on April 2008 and 11 December 2009, are also considered. Lastly, on the basis of the current existing guidelines and scientific evidence, the authors propose occupational health surveillance protocols for workers exposed to AOR risk

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