NEJM: 压力支持通气或 T 管的自主呼吸试验

Abstract

BACKGROUND

Spontaneous-breathing trials can be performed with the use of either pressure-support ventilation (PSV) or a T-piece. Whether PSV trials may result in a shorter time to tracheal extubation than T-piece trials, without resulting in a higher risk of reintubation, among patients who have a high risk of extubation failure is unknown.

可以使用压力支持通气 (PSV) 或 T 管进行自主呼吸试验。在拔管失败高风险的患者中，PSV 试验是否会比 T 管试验更短的气管拔管时间，而不会导致更高的再插管风险，目前尚不清楚。

METHODS

In this multicenter, open-label trial, we randomly assigned patients who had a high risk of extubation failure (i.e., were >65 years of age or had an underlying chronic cardiac or respiratory disease) to undergo spontaneous-breathing trials performed with the use of either PSV (with a pressure-support level of 8 cm of water and no positive end-expiratory pressure) or a T-piece. The primary outcome was the total time without exposure to invasive ventilation (reported as the number of ventilator-free days) at day 28 after the initial spontaneous-breathing trial. Secondary outcomes included extubation within 24 hours and extubation within 7 days after the initial spontaneous-breathing trial, as well as reintubation within 7 days after extubation.

在这项多中心、开放标签试验中，我们将拔管失败风险高的患者（即 >65 岁或患有潜在的慢性心脏或呼吸系统疾病）随机分配到使用PSV（压力支持水平为 8 厘米水柱且无呼气末正压）或 T 管。主要结果是在最初的自主呼吸试验后第 28 天未暴露于有创通气的总时间（报告为无呼吸机天数）。次要结局包括在初始自主呼吸试验后 24 小时内拔管和 7 天内拔管，以及拔管后 7 天内重新插管。

RESULTS

A total of 969 patients (484 in the PSV group and 485 in the T-piece group) were included in the analysis. At day 28, the median number of ventilator-free days was 27 (interquartile range, 24 to 27) in the PSV group and 27 (interquartile range, 23 to 27) in the T-piece group (difference, 0 days; 95% confidence interval [CI], −0.5 to 1; P=0.31). Extubation was performed within 24 hours in 376 patients (77.7%) in the PSV group and in 350 patients (72.2%) in the T-piece group (difference, 5.5 percentage points; 95% CI, 0.01 to 10.9), and extubation was performed within 7 days in 473 patients (97.7%) and 458 patients (94.4%), respectively (difference, 3.3 percentage points; 95% CI, 0.8 to 5.9). Reintubation was performed in 72 of 481 patients (14.9%) in the PSV group and in 65 of 477 patients (13.6%) in the T-piece group (difference, 1.3 percentage points; 95% CI, −3.1 to 5.8). Cardiac or respiratory arrest was a reason for reintubation in 9 patients (3 in the PSV group and 6 in the T-piece group).

共有 969 名患者（PSV 组 484 名，T 管组 485 名）被纳入分析。在第 28 天，PSV 组的中位无呼吸机天数为 27（四分位距，24 至 27），T 管组为 27 天（四分位距，23 至 27）（差异，0 天；95%置信区间 [CI]，-0.5 到 1；P=0.31）。PSV 组 376 例患者（77.7%）和 T 管组 350 例患者（72.2%）在 24 小时内拔管（差异，5.5 个百分点；95% CI，0.01 至 10.9），拔管是分别有 473 名患者 (97.7%) 和 458 名患者 (94.4%) 在 7 天内进行了检查（差异，3.3 个百分点；95% CI，0.8 至 5.9）。PSV 组 481 名患者中的 72 名（14.9%）和 T 管组 477 名患者中的 65 名（13.6%）进行了再插管（差异，1. 3个百分点；95% CI，-3.1 至 5.8）。心脏或呼吸停止是 9 名患者（PSV 组 3 名和 T 管组 6 名）重新插管的原因。

CONCLUSIONS

Among patients who had a high risk of extubation failure, spontaneous-breathing trials performed with PSV did not result in significantly more ventilator-free days at day 28 than spontaneous-breathing trials performed with a T-piece. (Supported by the French Ministry of Health; TIP-EX ClinicalTrials.gov number, NCT04227639. opens in new tab.)

在拔管失败高风险的患者中，与使用 T 管进行的自主呼吸试验相比，使用 PSV 进行的自主呼吸试验在第 28 天没有显着增加无呼吸机天数。（由法国卫生部提供支持；TIP-EX ClinicalTrials.gov 编号为NCT04227639 。）