荷兰阿姆斯特丹大学医学中心Angelique de Man团队研究了较低正常与较高正常氧合目标对危重患者器官功能障碍的影响。该研究于2021年8月31日发表于《美国医学会杂志》上。
将参与者随机分组，其中205例接受较低正常Pao2目标（9-12 kPa），195例接受较高正常Pao2目标（14-18 kPa）。只有在有临床指征时，才应用高于0.60的吸入氧分数。主要终点是SOFARANK，这是一种非呼吸性器官衰竭的分级结果，通过顺序器官衰竭评估（SOFA）评分的非呼吸性成分进行量化，在前14个研究日进行汇总。参与者从器官衰竭改善最快（得分最低）到器官衰竭恶化或死亡（得分最高）进行排序。次要终点为机械通气持续时间、住院死亡率和低氧血症测量。
Title: Effect of Low-Normal vs High-Normal Oxygenation Targets on Organ Dysfunction in Critically Ill Patients: A Randomized Clinical Trial
Author: Harry Gelissen, Harm-Jan de Grooth, Yvo Smulders, Evert-Jan Wils, Wouter de Ruijter, Roel Vink, Bob Smit, Jantine Rttgering, Leila Atmowihardjo, Armand Girbes, Paul Elbers, Pieter-Roel Tuinman, Heleen Oudemans-van Straaten, Angelique de Man
Importance Hyperoxemia may increase organ dysfunction in critically ill patients, but optimal oxygenation targets are unknown.
Objective To determine whether a low-normal Pao2 target compared with a high-normal target reduces organ dysfunction in critically ill patients with systemic inflammatory response syndrome (SIRS).
Design, Setting, and Participants Multicenter randomized clinical trial in 4 intensive care units in the Netherlands. Enrollment was from February 2015 to October 2018, with end of follow-up to January 2019, and included adult patients admitted with 2 or more SIRS criteria and expected stay of longer than 48 hours. A total of 9925 patients were screened for eligibility, of whom 574 fulfilled the enrollment criteria and were randomized.
Interventions Target Pao2 ranges were 8 to 12 kPa (low-normal, n=205) and 14 to 18 kPa (high-normal, n=195). An inspired oxygen fraction greater than 0.60 was applied only when clinically indicated.
Main Outcomes and Measures Primary end point was SOFARANK, a ranked outcome of nonrespiratory organ failure quantified by the nonrespiratory components of the Sequential Organ Failure Assessment (SOFA) score, summed over the first 14 study days. Participants were ranked from fastest organ failure improvement (lowest scores) to worsening organ failure or death (highest scores). Secondary end points were duration of mechanical ventilation, in-hospital mortality, and hypoxemic measurements.
Results Among the 574 patients who were randomized, 400 (70%) were enrolled within 24 hours (median age, 68 years; 140 women [35%]), all of whom completed the trial. The median Pao2 difference between the groups was -1.93 kPa (95% CI, 2.12 to 1.74; P<.001). The median SOFARANK score was 35 points in the low-normal Pao2 group vs 40 in the high-normal Pao2 group (median difference, 10 [95% CI, 0 to 21]; P=.06). There was no significant difference in median duration of mechanical ventilation (3.4 vs 3.1 days; median difference, 0.15 [95% CI, 0.88 to 0.47]; P=.59) and in-hospital mortality (32% vs 31%; odds ratio, 1.04 [95% CI, 0.67 to 1.63]; P=.91). Mild hypoxemic measurements occurred more often in the low-normal group (1.9% vs 1.2%; median difference, 0.73 [95% CI, 0.30 to 1.20]; P<.001). Acute kidney failure developed in 20 patients (10%) in the low-normal Pao2 group and 21 patients (11%) in the high-normal Pao2 group, and acute myocardial infarction in 6 patients (2.9%) in the low-normal Pao2 group and 7 patients (3.6%) in the high-normal Pao2 group.
Conclusions and Relevance Among critically ill patients with 2 or more SIRS criteria, treatment with a low-normal Pao2 target compared with a high-normal Pao2 target did not result in a statistically significant reduction in organ dysfunction. However, the study may have had limited power to detect a smaller treatment effect than was hypothesized.