發表於(NEJM, IF:70.67)
Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome
Barrot Loic,Asfar Pierre,Mauny Frederic et al. Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome.
BACKGROUND 背景
In patients with acute respiratory distress syndrome (ARDS), the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network recommends a target partial pressure of arterial oxygen (Pao2) between 55 and 80 mm Hg. Prospective validation of this range in patients with ARDS is lacking. We hypothesized that targeting the lower limit of this range would improve outcomes in patients with ARDS.
在急性呼吸窘迫綜合徵(ARDS)患者中,國家心、肺和血液研究所ARDS臨床試驗網路建議動脈血氧分壓(PaO2)的目標在55至80 mmHg之間。對ARDS患者該範圍的前瞻性驗證尚缺。我們假設,將目標鎖定在這個範圍的下限將改善ARDS患者的預後。
METHODS 方法
In this multicenter, randomized trial, we assigned patients with ARDS to receive either conservative oxygen therapy (target Pao2, 55 to 70 mm Hg; oxygen saturation as measured by pulse oximetry
在這項多中心隨機試驗中,我們將急性呼吸窘迫綜合徵患者分為保守氧療(目標PaO2,55~70 mmHg,SpO2, 88~92%)和自由氧療(目標PaO2,90~105 mmHg,SpO2,≥96%),治療7天。兩組採用相同的機械通氣策略。主要結局是在28天內死於任何原因。
RESULTS 結果
After the enrollment of 205 patients, the trial was prematurely stopped by the data and safety monitoring board because of safety concerns and a low likelihood of a significant difference between the two groups in the primary outcome. Four pa- tients who did not meet the eligibility criteria were excluded. At day 28, a total of 34 of 99 patients (34.3%) in the conservative-oxygen group and 27 of 102 patients (26.5%) in the liberal-oxygen group had died (difference, 7.8 percentage points; 95% confidence interval
在205名患者登記後,資料和安全監測委員會出於安全考慮和兩組患者在主要結局上存在顯著差異的低可能性,提前停止了試驗。四名不符合資格標準的患者被排除在外。在第28天,保守氧氣組99名患者中共有34名(34.3%)死亡,自由氧氣組102名患者中27名(26.5%)死亡(差異,7.8個百分點;95%可信區間
CONCLUSIONS 結論
Among patients with ARDS, early exposure to a conservative-oxygenation strategy with a Pao2 between 55 and 70 mm Hg did not increase survival at 28 days. (Funded by the French Ministry of Health; LOCO2 ClinicalTrials.gov number, NCT02713451.)
在ARDS患者中,早期暴露於動脈血氧分壓在55至70 mmHg之間的保守氧合策略並不能增加28天的存活率。(由法國衛生部資助;LOCO2 ClinicalTrials.gov編號,NCT02713451)