Université Lyon 1, Université de Lyon, Lyon, France.
Medical Intensive Care Unit, Croix-Rousse Hospital, Hospices Civils de Lyon, 103 Grande Rue de la Croix Rousse, 69004, Lyon, France.
Trials. 2021 Oct 11;22(1):692. doi: 10.1186/s13063-021-05665-z.
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 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.
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/FiO 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 PBW), and the intervention group will be ventilated with ULTV (tidal volume 4 mL kg 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.
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.
ClinicalTrials.gov NCT04349618 . Registered on April 16, 2020.
急性呼吸窘迫综合征（ARDS）是 COVID-19 肺炎的一种严重并发症，中重度 ARDS 的死亡率达到 34-50%，与有创机械通气时间延长有关。与非 COVID-19 ARDS 一样，有害的机械通气设置可能与更差的结果相关。将潮气量降低到预测体重的 4ml/kg（PBW）以提供超低潮气量通气（ULTV）是一种有吸引力的技术，可以最大限度地减少呼吸机诱导的肺损伤。此外，在全球大流行的背景下，它不需要任何额外的材料和耗材，并且可以在中低收入国家应用。我们假设，无需体外循环的 ULTV 是降低 COVID-19 相关 ARDS 死亡率和机械通气时间的一种可靠选择。
VT4COVID 研究是一项随机、多中心前瞻性开放标签对照优效性试验。成人患者因 COVID-19 相关的轻度至重度 ARDS 而入住重症监护病房，定义为 PaO/FiO 比值≤150mmHg，在有创机械通气下少于 48 小时，并同意参与研究，将有资格入组。患者将以 1:1 的比例随机分为两组。对照组将接受保护性通气设置（潮气量 6ml/kg PBW），干预组将接受 ULTV（潮气量 4ml/kg PBW）。主要结局是基于 90 天全因死亡率的复合评分，作为优先标准和纳入后第 60 天无呼吸机天数。随机分组表将按招募地点分层，并使用大小为 4 和 6 的随机块生成。将使用意向治疗原则进行数据分析。
本手稿的目的是提供研究方案的主要出版物，以防止结果的选择性报告、数据驱动的分析和提高透明度。研究的患者入组正在进行中。
ClinicalTrials.gov NCT04349618。于 2020 年 4 月 16 日注册。
