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[JAMA在线发表]:高流量鼻导管氧疗不能降低合并急性呼吸功能衰竭的免疫功能抑制患者28天病死率
2018年11月11日 时讯速递, 进展交流 暂无评论

Original Investigation

Caring for the Critically Ill Patient

October 24, 2018

Effect of High-Flow Nasal Oxygen vs Standard Oxygen on 28-Day Mortality in Immunocompromised Patients With Acute Respiratory Failure: The HIGH Randomized Clinical Trial

Elie Azoulay, Virginie Lemiale, Djamel Mokart, et al

JAMA. Published online October 24, 2018. doi:10.1001/jama.2018.14282

Abstract

Importance 背景

High-flow nasal oxygen therapy is increasingly used for acute hypoxemic respiratory failure (AHRF).

高流量鼻导管氧疗越来越多地用于急性低氧性呼吸功能衰竭(AHRF)。

Objective 目的

To determine whether high-flow oxygen therapy decreases mortality among immunocompromised patients with AHRF compared with standard oxygen therapy.

与标准氧疗相比,明确高流量鼻导管氧疗是否能够降低合并AHRF的免疫功能抑制患者病死率。

Design, Setting, and Participants 设计、场景和研究人群

The HIGH randomized clinical trial enrolled 776 adult immunocompromised patients with AHRF (Pao2 <60 mm Hg or Spo2 <90% on room air, or tachypnea >30/min or labored breathing or respiratory distress, and need for oxygen ≥6 L/min) at 32 intensive care units (ICUs) in France between May 19, 2016, and December 31, 2017.

2016年5月19日至2017年12月31日期间,在法国32个ICU进行的HIGH随机临床试验入选776名合并AHRF(吸空气Pao2 <60 mmHg 或 Spo2 <90%,或呼吸频数 >30/min或呼吸困难或呼吸窘迫,需要吸氧 ≥6 L/min)的成年免疫功能抑制患者。

Interventions 干预措施

Patients were randomized 1:1 to continuous high-flow oxygen therapy (n = 388) or to standard oxygen therapy (n = 388).

患者按照1:1的比例被随机分为持续高流量氧疗(n = 388)或标准氧疗(n = 388)组。

Main Outcomes and Measures 主要预后指标

The primary outcome was day-28 mortality. Secondary outcomes included intubation and mechanical ventilation by day 28, Pao2:Fio2 ratio over the 3 days after intubation, respiratory rate, ICU and hospital lengths of stay, ICU-acquired infections, and patient comfort and dyspnea.

主要预后指标为28天病死率。次要预后指标包括28天时气管插管和机械通气,插管后3天内Pao2:Fio2 比值,呼吸频率,ICU和医院住院日,ICU获得性感染,患者舒适程度及呼吸困难。

Results 结果

Of 778 randomized patients (median age, 64 [IQR, 54-71] years; 259 [33.3%] women), 776 (99.7%) completed the trial. At randomization, median respiratory rate was 33/min (IQR, 28-39) vs 32 (IQR, 27-38) and Pao2:Fio2 was 136 (IQR, 96-187) vs 128 (IQR, 92-164) in the intervention and control groups, respectively. Median SOFA score was 6 (IQR, 4-8) in both groups. Mortality on day 28 was not significantly different between groups (35.6% vs 36.1%; difference, −0.5% [95% CI, −7.3% to +6.3%]; hazard ratio, 0.98 [95% CI, 0.77 to 1.24]; P = .94). Intubation rate was not significantly different between groups (38.7% vs 43.8%; difference, −5.1% [95% CI, −12.3% to +2.0%]). Compared with controls, patients randomized to high-flow oxygen therapy had a higher Pao2:Fio2 (150 vs 119; difference, 19.5 [95% CI, 4.4 to 34.6]) and lower respiratory rate after 6 hours (25/min vs 26/min; difference, −1.8/min [95% CI, −3.2 to −0.2]). No significant difference was observed in ICU length of stay (8 vs 6 days; difference, 0.6 [95% CI, −1.0 to +2.2]), ICU-acquired infections (10.0% vs 10.6%; difference, −0.6% [95% CI, −4.6 to +4.1]), hospital length of stay (24 vs 27 days; difference, −2 days [95% CI, −7.3 to +3.3]), or patient comfort and dyspnea scores.

接受随机分组的 778 名患者(中位年龄,64 [IQR, 54-71] 岁;259 [33.3%] 名女性)中,776 名 (99.7%) 完成了临床试验。随机分组时,干预组及对照组呼吸频率中位数分别为 33/min (IQR, 28-39) vs 32 (IQR, 27-38),Pao2:Fio2 比值分别为136 (IQR, 96-187) vs 128 (IQR, 92-164)。两组患者SOFA评分中位数均为 6 (IQR, 4-8)。28天病死率无明显组间差异(35.6% vs 36.1%;差异,−0.5% [95% CI, −7.3% to +6.3%]; 风险比,0.98 [95% CI, 0.77 to 1.24]; P = .94)。两组间气管插管比例无显著差异(38.7% vs 43.8%; 差异, −5.1% [95% CI, −12.3% to +2.0%])。与对照组相比,高流量氧疗组患者 Pao2:Fio2 较高(150 vs 119; 差异, 19.5 [95% CI, 4.4 to 34.6]),6小时后呼吸频率更慢(25/min vs 26/min; 差异, −1.8/min [95% CI, −3.2 to −0.2])。ICU住院日(8 vs 6 天; 差异, 0.6 [95% CI, −1.0 to +2.2]),ICU获得性感染率(10.0% vs 10.6%; 差异, −0.6% [95% CI, −4.6 to +4.1]),医院住院日(24 vs 27 天;差异, −2 天 [95% CI, −7.3 to +3.3])或患者舒适感及呼吸困难评分无显著差异。

Conclusions and Relevance 结论与意义

Among critically ill immunocompromised patients with acute respiratory failure, high-flow oxygen therapy did not significantly decrease day-28 mortality compared with standard oxygen therapy.

对于合并急性呼吸功能衰竭的免疫功能抑制患者,与标准氧疗相比,高流量氧疗不能显著降低28天病死率。

Trial Registration

clinicaltrials.gov Identifier: NCT02739451.

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