机械通气患者的保守与自由氧合目标：一项多中心随机对照试验的初步研究。

Conservative versus Liberal Oxygenation Targets for Mechanically Ventilated Patients. A Pilot Multicenter Randomized Controlled Trial.

机构信息

1 Intensive Care Unit, John Hunter Hospital, Newcastle, Australia.

2 School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.

出版信息

Am J Respir Crit Care Med. 2016 Jan 1;193(1):43-51. doi: 10.1164/rccm.201505-1019OC.

DOI:10.1164/rccm.201505-1019OC

PMID:26334785

Abstract

RATIONALE

There are no randomized controlled trials comparing different oxygenation targets for intensive care unit (ICU) patients.

OBJECTIVES

To determine whether a conservative oxygenation strategy is a feasible alternative to a liberal oxygenation strategy among ICU patients requiring invasive mechanical ventilation (IMV).

METHODS

At four multidisciplinary ICUs, 103 adult patients deemed likely to require IMV for greater than or equal to 24 hours were randomly allocated to either a conservative oxygenation strategy with target oxygen saturation as measured by pulse oximetry (SpO2) of 88-92% (n = 52) or a liberal oxygenation strategy with target SpO2 of greater than or equal to 96% (n = 51).

MEASUREMENTS AND MAIN RESULTS

The mean area under the curve and 95% confidence interval (CI) for SpO2 (93.4% [92.9-93.9%] vs. 97% [96.5-97.5%]), SaO2 (93.5% [93.1-94%] vs. 96.8% [96.3-97.3%]), PaO2 (70 [68-73] mm Hg vs. 92 [89-96] mm Hg), and FiO2 (0.26 [0.25-0.28] vs. 0.36 [0.34-0.39) in the conservative versus liberal oxygenation arm were significantly different (P < 0.0001 for all). There were no significant between-group differences in any measures of new organ dysfunction, or ICU or 90-day mortality. The percentage time spent with SpO2 less than 88% in conservative versus liberal arm was 1% versus 0.3% (P = 0.03), and percentage time spent with SpO2 greater than 98% in conservative versus liberal arm was 4% versus 22% (P < 0.001). The adjusted hazard ratio for 90-day mortality in the conservative arm was 0.77 (95% CI, 0.40-1.50; P = 0.44) overall and 0.49 (95% CI, 0.20-1.17; P = 0.10) in the prespecified subgroup of patients with a baseline PaO2/FiO2 less than 300.

CONCLUSIONS

Our study supports the feasibility of a conservative oxygenation strategy in patients receiving IMV. Larger randomized controlled trials of this intervention appear justified. Clinical trial registered with Australian New Zealand Clinical Trials Registry (ACTRN 12613000505707).

摘要

背景

目前尚无比较重症监护病房（ICU）患者不同氧合目标的随机对照试验。

目的

旨在确定在需要有创机械通气（IMV）的 ICU 患者中，采用保守氧合策略是否是一种可行的选择，而不是采用自由氧合策略。

方法

在四个多学科 ICU 中，将 103 名成人患者随机分配到保守氧合策略组（脉搏血氧饱和度测量值为 88-92%，目标氧饱和度[SpO2]）或自由氧合策略组（目标 SpO2大于或等于 96%），这些患者预计需要 IMV 治疗超过 24 小时。

测量和主要结果

SpO2（93.4%[92.9-93.9%] vs. 97%[96.5-97.5%]）、SaO2（93.5%[93.1-94%] vs. 96.8%[96.3-97.3%]）、PaO2（70[68-73]mmHg vs. 92[89-96]mmHg）和 FiO2（0.26[0.25-0.28] vs. 0.36[0.34-0.39]）在保守组与自由组之间的曲线下面积和 95%置信区间（CI）差异均有统计学意义（所有 P<0.0001）。在任何新器官功能障碍或 ICU 或 90 天死亡率的指标方面，两组之间均无显著差异。与自由组相比，保守组 SpO2 低于 88%的时间百分比为 1%，而 0.3%（P=0.03），SpO2 大于 98%的时间百分比为 4%，而 22%（P<0.001）。在保守组中，90 天死亡率的调整后危险比为 0.77（95%CI，0.40-1.50；P=0.44），在基线 PaO2/FiO2 小于 300 的预设亚组中为 0.49（95%CI，0.20-1.17；P=0.10）。