补充氧气通常用于创伤患者,尽管它可能导致与肺部并发症和死亡率增加相关的高氧血症。这次审判的主要目的,TRAUMOX2是在创伤后的前8小时比较限制性和自由氧气策略。
TRAUMOX2是由调查员发起的,国际,平行分组,优越性,结果评估者盲化和分析师盲化,随机化,控制,临床试验。怀疑有重大创伤的成年患者被随机分配到限制性或宽松的氧气策略的八小时。限制性组接受最低剂量的氧气(>21%),以确保SpO2为94%。自由组接受12-15LO2/min或FiO2=0.6-1.0。主要结果是30天死亡率和/或主要呼吸系统并发症(肺炎和/或急性呼吸窘迫综合征)的发展的综合结果。每个手臂上有710名参与者,如果自由主义者组的主要结局发生率为15%,我们将能够检测到限制性吸氧策略的风险降低33%.
TRAUMOX2是根据赫尔辛基二世宣言进行的。它已获得丹麦首都地区卫生研究伦理委员会(H-21018062)和丹麦药品管理局的批准,以及荷兰医学研究伦理委员会伊拉斯谟MS(NL79921.078.21和MEC-2021-0932)。一个网站(www。traumox2.org)可供更新,研究结果将发表在国际同行评审的科学杂志上。
欧洲2021-000556-19;NCT05146700。
Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma.
TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial.Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (>21%) that ensures an SpO2 of 94%. The liberal group receives 12-15 L O2/min or FiO2=0.6-1.0.The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome).With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group.
TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal.
EudraCT 2021-000556-19; NCT05146700.