急性呼吸窘迫综合征的自由或保守氧疗。

Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome.

机构信息

From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).

出版信息

N Engl J Med. 2020 Mar 12;382(11):999-1008. doi: 10.1056/NEJMoa1916431.

DOI:10.1056/NEJMoa1916431

PMID:32160661

Abstract

BACKGROUND

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 (Pao) 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.

METHODS

In this multicenter, randomized trial, we assigned patients with ARDS to receive either conservative oxygen therapy (target Pao, 55 to 70 mm Hg; oxygen saturation as measured by pulse oximetry [Spo], 88 to 92%) or liberal oxygen therapy (target Pao, 90 to 105 mm Hg; Spo, ≥96%) for 7 days. The same mechanical-ventilation strategies were used in both groups. The primary outcome was death from any cause at 28 days.

RESULTS

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 patients 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 [CI], -4.8 to 20.6). At day 90, 44.4% of the patients in the conservative-oxygen group and 30.4% of the patients in the liberal-oxygen group had died (difference, 14.0 percentage points; 95% CI, 0.7 to 27.2). Five mesenteric ischemic events occurred in the conservative-oxygen group.

CONCLUSIONS

Among patients with ARDS, early exposure to a conservative-oxygenation strategy with a Pao between 55 and 70 mm Hg did not increase survival at 28 days. (Funded by the French Ministry of Health; LOCO ClinicalTrials.gov number, NCT02713451.).

摘要

背景

在急性呼吸窘迫综合征（ARDS）患者中，美国国立心肺血液研究所 ARDS 临床试验网络建议将动脉血氧分压（Pao）目标值设定在 55 至 80mmHg 之间。但目前尚缺乏对这一范围在 ARDS 患者中进行前瞻性验证的研究。我们假设将该范围的下限作为目标值可能会改善 ARDS 患者的结局。

方法

在这项多中心、随机试验中，我们将 ARDS 患者分为两组，分别接受保守氧疗（目标 Pao 为 55 至 70mmHg；脉搏血氧饱和度[SpO2]测量值为 88 至 92%）或宽松氧疗（目标 Pao 为 90 至 105mmHg；SpO2≥96%），疗程均为 7 天。两组均采用相同的机械通气策略。主要结局为 28 天内的全因死亡率。

结果

在纳入 205 例患者后，由于安全性问题和两组主要结局之间不太可能存在显著差异，数据和安全监测委员会提前终止了试验。排除了不符合入选标准的 4 例患者。28 天时，保守氧疗组 99 例患者中有 34 例（34.3%）和宽松氧疗组 102 例患者中有 27 例（26.5%）死亡（差异为 7.8 个百分点；95%置信区间[CI]为-4.8 至 20.6）。90 天时，保守氧疗组 44.4%的患者和宽松氧疗组 30.4%的患者死亡（差异为 14.0 个百分点；95%CI 为 0.7 至 27.2）。保守氧疗组发生 5 例肠系膜缺血事件。