心脏骤停昏迷幸存者的氧目标。

Oxygen Targets in Comatose Survivors of Cardiac Arrest.

机构信息

From the Departments of Anesthesiology and Intensive Care (H.S., S.M., S.V., D.M.) and Cardiology (B.B., L.S., L.O.J., J.E.M.), Odense University Hospital, and the Department of Clinical Research, University of Southern Denmark (H.S., C.H., B.B., L.O.J., J.E.M.), Odense, and the Departments of Cardiology (J.K., C.H., J.G., L.E.R.O., B.N., D.E.H., J.J., J.H.T., M.G.L., M.A.S.M., M.F., M.W.-J., R.P.B., R.F.-S., S.W., S.B., J.E.M.) and Cardiothoracic Anesthesiology (M.S., V.L.J.), the Heart Center, and the Department of Clinical Biochemistry, Center of Diagnostic Investigation (R.F.-S.), Copenhagen University Hospital Rigshospitalet, the Department of Clinical Medicine, University of Copenhagen (J.K., C.H., R.F.-S.), and the Department of Cardiology, Copenhagen University Hospital Bispebjerg (J.J.T.), Copenhagen - all in Denmark.

出版信息

N Engl J Med. 2022 Oct 20;387(16):1467-1476. doi: 10.1056/NEJMoa2208686. Epub 2022 Aug 27.

DOI:10.1056/NEJMoa2208686

PMID:36027567

Abstract

BACKGROUND

The appropriate oxygenation target for mechanical ventilation in comatose survivors of out-of-hospital cardiac arrest is unknown.

METHODS

In this randomized trial with a 2-by-2 factorial design, we randomly assigned comatose adults with out-of-hospital cardiac arrest in a 1:1 ratio to either a restrictive oxygen target of a partial pressure of arterial oxygen (Pao) of 9 to 10 kPa (68 to 75 mm Hg) or a liberal oxygen target of a Pao of 13 to 14 kPa (98 to 105 mm Hg); patients were also assigned to one of two blood-pressure targets (reported separately). The primary outcome was a composite of death from any cause or hospital discharge with severe disability or coma (Cerebral Performance Category [CPC] of 3 or 4; categories range from 1 to 5, with higher values indicating more severe disability), whichever occurred first within 90 days after randomization. Secondary outcomes were neuron-specific enolase levels at 48 hours, death from any cause, the score on the Montreal Cognitive Assessment (ranging from 0 to 30, with higher scores indicating better cognitive ability), the score on the modified Rankin scale (ranging from 0 to 6, with higher scores indicating greater disability), and the CPC at 90 days.

RESULTS

A total of 789 patients underwent randomization. A primary-outcome event occurred in 126 of 394 patients (32.0%) in the restrictive-target group and in 134 of 395 patients (33.9%) in the liberal-target group (hazard ratio, 0.95; 95% confidence interval, 0.75 to 1.21; P = 0.69). At 90 days, death had occurred in 113 patients (28.7%) in the restrictive-target group and in 123 (31.1%) in the liberal-target group. On the CPC, the median category was 1 in the two groups; on the modified Rankin scale, the median score was 2 in the restrictive-target group and 1 in the liberal-target group; and on the Montreal Cognitive Assessment, the median score was 27 in the two groups. At 48 hours, the median neuron-specific enolase level was 17 μg per liter in the restrictive-target group and 18 μg per liter in the liberal-target group. The incidence of adverse events was similar in the two groups.

CONCLUSIONS

Targeting of a restrictive or liberal oxygenation strategy in comatose patients after resuscitation for cardiac arrest resulted in a similar incidence of death or severe disability or coma. (Funded by the Novo Nordisk Foundation; BOX ClinicalTrials.gov number, NCT03141099.).

摘要

背景

机械通气在院外心脏骤停昏迷幸存者中的适当氧合目标尚不清楚。

方法

在这项随机、2×2 析因设计的试验中，我们以 1:1 的比例随机分配院外心脏骤停的昏迷成年患者接受限制氧目标（动脉氧分压[Pao]为 9 至 10 kPa[68 至 75 mmHg]）或宽松氧目标（Pao 为 13 至 14 kPa[98 至 105 mmHg]）；患者还被分配到两个血压目标之一（分别报告）。主要结局是 90 天内任何原因导致的死亡或伴有严重残疾或昏迷（Cerebral Performance Category [CPC]为 3 或 4；类别范围为 1 至 5，分值越高表示残疾越严重）。次要结局是 48 小时时神经元特异性烯醇化酶水平、任何原因导致的死亡、蒙特利尔认知评估（范围为 0 至 30，分值越高表示认知能力越好）、改良 Rankin 量表（范围为 0 至 6，分值越高表示残疾越严重）和 90 天时的 CPC。

结果

共有 789 名患者接受了随机分组。限制目标组 394 名患者中有 126 例（32.0%）和宽松目标组 395 名患者中有 134 例（33.9%）发生主要结局事件（风险比，0.95；95%置信区间，0.75 至 1.21；P=0.69）。90 天时，限制目标组 113 例（28.7%）和宽松目标组 123 例（31.1%）患者死亡。在 CPC 方面，两组的中位数类别均为 1；在改良 Rankin 量表上，限制目标组的中位数评分为 2，宽松目标组的中位数评分为 1；在蒙特利尔认知评估上，两组的中位数评分为 27。48 小时时，限制目标组神经元特异性烯醇化酶中位数为 17μg/L，宽松目标组为 18μg/L。两组不良事件发生率相似。