Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit The Oxygen-ICU Randomized Clinical Trial
Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit The Oxygen-ICU Randomized Clinical Trial
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DOI：
10.1001/jama.2016.11993
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发表时间：
2016-10-18
影响因子：
120.7
通讯作者：
Singer, Mervyn
中科院分区：
文献类型：
--
作者：
Girardis, Massimo;Busani, Stefano;Singer, Mervyn
重要性尽管不必要的氧疗有潜在的危害，但危重患者仍有相当长的时间处于高血氧状态。因此，控制动脉氧合的策略是合理的，但尚未在临床实践中得到验证。2010年3月至2012年10月进行的随机临床试验，纳入了预期住院时间为72小时或更长时间的所有成年人，这些患者入住了意大利摩德纳大学医院的内外科ICU。最初计划的样本量为660例患者，但在纳入480例患者后，由于招募困难而提前停止了研究。干预患者被随机分配接受氧疗，以维持PaO2在70和100 mm Hg之间或动脉血氧饱和度（SpO（2））在94%和98%之间（保守组）或根据标准ICU实践，允许PaO 2值高达150 mmHg或SpO（2）值在97%和100%之间（常规对照组）。次要结果包括发生新的器官衰竭和感染后48小时或更长的ICU accounting.Results共434例患者（中位年龄，64岁，188 [43.3%]女性）接受传统（n = 218）或保守（n = 216）氧治疗，并被纳入修改后的意向治疗分析。ICU期间每日时间加权PaO2平均值显著高于（P
IMPORTANCE Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice.OBJECTIVE To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs).DESIGN, SETTING, AND PATIENTS Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients.INTERVENTIONS Patients were randomly assigned to receive oxygen therapy to maintain PaO2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (SpO(2)) between 94% and 98%(conservative group) or, according to standard ICU practice, to allow PaO2 values up to 150 mm Hg or SpO(2) values between 97% and 100% (conventional control group).MAIN OUTCOMES AND MEASURES The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission.RESULTS A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted PaO2 averages during the ICU stay were significantly higher (P