Background Acute respiratory distress syndrome (ARDS) is a severe complication of COVID-19 pneumonia, with a mortality rate amounting to 34–50% in moderate and severe ARDS, and is associated with prolonged duration of invasive mechanical ventilation. Such as in non-COVID ARDS, harmful mechanical ventilation settings might be associated with worse outcomes. Reducing the tidal volume down to 4 mL kg −1 of predicted body weight (PBW) to provide ultra-low tidal volume ventilation (ULTV) is an appealing technique to minimize ventilator-inducted lung injury. Furthermore, in the context of a worldwide pandemic, it does not require any additional material and consumables and may be applied in low- to middle-income countries. We hypothesized that ULTV without extracorporeal circulation is a credible option to reduce COVID-19-related ARDS mortality and duration of mechanical ventilation. Methods The VT4COVID study is a randomized, multi-centric prospective open-labeled, controlled superiority trial. Adult patients admitted in the intensive care unit with COVID-19-related mild to severe ARDS defined by a PaO 2 /FiO 2 ratio ≤ 150 mmHg under invasive mechanical ventilation for less than 48 h, and consent to participate to the study will be eligible. Patients will be randomized into two balanced parallels groups, at a 1:1 ratio. The control group will be ventilated with protective ventilation settings (tidal volume 6 mL kg −1 PBW), and the intervention group will be ventilated with ULTV (tidal volume 4 mL kg −1 PBW). The primary outcome is a composite score based on 90-day all-cause mortality as a prioritized criterion and the number of ventilator-free days at day 60 after inclusion. The randomization list will be stratified by site of recruitment and generated using random blocks of sizes 4 and 6. Data will be analyzed using intention-to-treat principles. Discussion The purpose of this manuscript is to provide primary publication of study protocol to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency. Enrollment of patients in the study is ongoing. Trial registration ClinicalTrials.gov NCT04349618 . Registered on April 16, 2020 Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05665-z.
【저자키워드】 COVID-19, SARS-CoV-2, acute respiratory distress syndrome, mechanical ventilation, Ultraprotective ventilation, Ultra-low tidal volume ventilation, Tidal volume, 【초록키워드】 Respiratory distress syndrome, ARDS, COVID-19 pneumonia, Mortality, Trial, Study protocol, intensive care, acute respiratory distress syndrome, mechanical ventilation, Pneumonia, body weight, Ventilation, intensive care unit, Lung injury, outcomes, Randomized, Patient, Mild, Ventilator-free days, Tidal volume, Transparency, mortality rate, circulation, recruitment, moderate, Protective, Invasive mechanical ventilation, Analysis, distress, respiratory distress, extracorporeal circulation, Volume, Ventilated, Primary outcome, ventilator, control group, intervention group, Trial registration, supplementary material, Adult patients, worldwide pandemic, severe ARDS, all-cause mortality, syndrome, randomization list, criterion, treat, intention-to-treat, manuscript, random, selective, consumables, complication of COVID-19, block, Inclusion, data-driven, Prevent, defined, predicted, analyzed, less, reduce, groups, stratified, 1:1, Adult patient, eligible, PaO, ventilator-free day, 【제목키워드】 Randomized controlled trial, Trial, Pneumonia, Ventilation, circulation, moderate, patients with COVID-19,