Early pathophysiology-driven airway pressure release ventilation versus low tidal volume ventilation strategy for patients with moderate-severe ARDS: study protocol for a randomized, multicenter, controlled trial

被引:1
|
作者
Zhou, Yongfang [1 ]
Cheng, Jiangli [1 ]
Zhu, Shuo [1 ]
Dong, Meiling [1 ]
Lv, Yinxia [1 ]
Jing, Xiaorong [1 ]
Kang, Yan [2 ]
机构
[1] Sichuan Univ, West China Hosp, Dept Resp Care, Guoxue Alley 37, Chengdu 610041, Sichuan, Peoples R China
[2] Sichuan Univ, West China Hosp, Dept Crit Care Med, Guoxue Alley 37, Chengdu 610041, Sichuan, Peoples R China
来源
BMC PULMONARY MEDICINE | 2024年 / 24卷 / 01期
关键词
Acute respiratory syndrome distress; Airway pressure release ventilation; Low tidal volume; Mechanical ventilation; Randomized controlled trial; RESPIRATORY-DISTRESS-SYNDROME; MECHANICAL VENTILATION; ADULT PATIENTS; LUNG INJURY; RECRUITMENT; CARE; DERECRUITMENT; GUIDELINES; PHYSIOLOGY; TIME;
D O I
10.1186/s12890-024-03065-y
中图分类号
R56 [呼吸系及胸部疾病];
学科分类号
摘要
Background Conventional Mechanical ventilation modes used for individuals suffering from acute respiratory distress syndrome have the potential to exacerbate lung injury through regional alveolar overinflation and/or repetitive alveolar collapse with shearing, known as atelectrauma. Animal studies have demonstrated that airway pressure release ventilation (APRV) offers distinct advantages over conventional mechanical ventilation modes. However, the methodologies for implementing APRV vary widely, and the findings from clinical studies remain controversial. This study (APRVplus trial), aims to assess the impact of an early pathophysiology-driven APRV ventilation approach compared to a low tidal volume ventilation (LTV) strategy on the prognosis of patients with moderate to severe ARDS.Methods The APRVplus trial is a prospective, multicenter, randomized clinical trial, building upon our prior single-center study, to enroll 840 patients from at least 35 hospitals in China. This investigation plans to compare the early pathophysiology-driven APRV ventilation approach with the control intervention of LTV lung-protective ventilation. The primary outcome measure will be all-cause mortality at 28 days after randomization in the intensive care units (ICU). Secondary outcome measures will include assessments of oxygenation, and physiology parameters at baseline, as well as on days 1, 2, and 3. Additionally, clinical outcomes such as ventilator-free days at 28 days, duration of ICU and hospital stay, ICU and hospital mortality, and the occurrence of adverse events will be evaluated.Methods The APRVplus trial is a prospective, multicenter, randomized clinical trial, building upon our prior single-center study, to enroll 840 patients from at least 35 hospitals in China. This investigation plans to compare the early pathophysiology-driven APRV ventilation approach with the control intervention of LTV lung-protective ventilation. The primary outcome measure will be all-cause mortality at 28 days after randomization in the intensive care units (ICU). Secondary outcome measures will include assessments of oxygenation, and physiology parameters at baseline, as well as on days 1, 2, and 3. Additionally, clinical outcomes such as ventilator-free days at 28 days, duration of ICU and hospital stay, ICU and hospital mortality, and the occurrence of adverse events will be evaluated.Trial ethics and dissemination The research project has obtained approval from the Ethics Committee of West China Hospital of Sichuan University (2019-337). Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.Trial registration The study was registered at Clinical Trials.gov (NCT03549910) on June 8, 2018.
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页数:13
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