PDF(Pubmed)
Abstract：
BACKGROUND: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear.
OBJECTIVE: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia.
METHODS: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance.
RESULTS: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide.
CONCLUSIONS: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.
OBJECTIVE: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia.
METHODS: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance.
RESULTS: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide.
CONCLUSIONS: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.
摘要：
背景：在急性呼吸窘迫综合征的观察性研究中，驱动压力被认为是呼吸机引起的肺损伤和死亡的主要驱动因素。驱动压力限制策略是否可以改善临床结果尚不清楚。
目的：描述方案和统计分析计划，用于测试在增加社区获得性肺炎急性呼吸窘迫综合征患者的无呼吸机天数方面，包括根据最佳呼吸顺应性和减少潮气量的呼气末正压滴定在内的驱动压力限制策略是否优于使用ARDSNet低呼气末正压表的标准策略。
方法：用于免疫获得性pNeumoniA（STAMINA）的呼吸机STrAtegy研究是一项随机研究，多中心，在重症监护病房因社区获得性肺炎导致的中度至重度急性呼吸窘迫综合征患者中，将驱动压力限制策略与ARDSnet低呼气末正压表进行比较的开放标签试验。我们预计将从20个巴西和2个哥伦比亚重症监护病房招募500名患者。他们将被随机分配到驱动压力限制策略组或使用ARDSNet低正呼气末压力表的标准策略。在驾驶压力限制策略组中，呼气末正压将根据最佳呼吸系统顺应性进行滴定。
结果：主要结果是28天内的无呼吸机天数。次要结果是住院和重症监护病房的死亡率，以及对体外生命支持等抢救治疗的需求。招募演习和吸入一氧化氮。
结论：STAMINA旨在提供证据，证明在中度至重度急性呼吸窘迫综合征患者的28天内，驱动压力限制策略是否优于ARDSNet低呼气末正压列表策略。这里,我们描述了基本原理，试验的设计和现状。
目的：描述方案和统计分析计划，用于测试在增加社区获得性肺炎急性呼吸窘迫综合征患者的无呼吸机天数方面，包括根据最佳呼吸顺应性和减少潮气量的呼气末正压滴定在内的驱动压力限制策略是否优于使用ARDSNet低呼气末正压表的标准策略。
方法：用于免疫获得性pNeumoniA（STAMINA）的呼吸机STrAtegy研究是一项随机研究，多中心，在重症监护病房因社区获得性肺炎导致的中度至重度急性呼吸窘迫综合征患者中，将驱动压力限制策略与ARDSnet低呼气末正压表进行比较的开放标签试验。我们预计将从20个巴西和2个哥伦比亚重症监护病房招募500名患者。他们将被随机分配到驱动压力限制策略组或使用ARDSNet低正呼气末压力表的标准策略。在驾驶压力限制策略组中，呼气末正压将根据最佳呼吸系统顺应性进行滴定。
结果：主要结果是28天内的无呼吸机天数。次要结果是住院和重症监护病房的死亡率，以及对体外生命支持等抢救治疗的需求。招募演习和吸入一氧化氮。
结论：STAMINA旨在提供证据，证明在中度至重度急性呼吸窘迫综合征患者的28天内，驱动压力限制策略是否优于ARDSNet低呼气末正压列表策略。这里,我们描述了基本原理，试验的设计和现状。
