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高流量鼻导管吸氧与传统氧疗用于新型冠状病毒肺炎合并轻度低氧血症患者的疗效比较：一项随机对照试验

High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial.

作者信息

Crimi Claudia, Noto Alberto, Madotto Fabiana, Ippolito Mariachiara, Nolasco Santi, Campisi Raffaele, De Vuono Stefano, Fiorentino Giuseppe, Pantazopoulos Ioannis, Chalkias Athanasios, Libra Alessandro, Mattei Alessio, Scala Raffaele, Clini Enrico M, Ergan Begum, Lujan Manel, Winck Joao Carlos, Giarratano Antonino, Carlucci Annalisa, Gregoretti Cesare, Groff Paolo, Cortegiani Andrea

机构信息

Respiratory Medicine Unit, Policlinico "G. Rodolico-San Marco" University Hospital, Catania, Italy.

Department of Human Pathology of the Adult and Evolutive Age "Gaetano Barresi", Division of Anesthesia and Intensive Care, University of Messina, Policlinico "G. Martino", Messina, Italy.

出版信息

Thorax. 2023 Apr;78(4):354-361. doi: 10.1136/thoraxjnl-2022-218806. Epub 2022 May 17.

DOI:10.1136/thoraxjnl-2022-218806

PMID:35580898

Abstract

RATIONALE

In patients with COVID-19 pneumonia and mild hypoxaemia, the clinical benefit of high-flow nasal oxygen (HFNO) remains unclear. We aimed to examine whether HFNO compared with conventional oxygen therapy (COT) could prevent escalation of respiratory support in this patient population.

METHODS

In this multicentre, randomised, parallel-group, open-label trial, patients with COVID-19 pneumonia and peripheral oxygen saturation (SpO) ≤92% who required oxygen therapy were randomised to HFNO or COT. The primary outcome was the rate of escalation of respiratory support (ie, continuous positive airway pressure, non-invasive ventilation or invasive mechanical ventilation) within 28 days. Among secondary outcomes, clinical recovery was defined as the improvement in oxygenation (SpO ≥96% with fractional inspired oxygen (FiO) ≤30% or partial pressure of arterial carbon dioxide/FiO ratio >300 mm Hg).

RESULTS

Among 364 randomised patients, 55 (30.3%) of 181 patients assigned to HFNO and 70 (38.6%) of 181 patients assigned to COT underwent escalation of respiratory support, with no significant difference between groups (absolute risk difference -8.2% (95% CI -18% to +1.4%); RR 0.79 (95% CI 0.59 to 1.05); p=0.09). There was no significant difference in clinical recovery (69.1% vs 60.8%; absolute risk difference 8.2% (95% CI -1.5% to +18.0%), RR 1.14 (95% CI 0.98 to 1.32)), intensive care unit admission (7.7% vs 11.0%, absolute risk difference -3.3% (95% CI -9.3% to +2.6%)), and in hospital length of stay (11 (IQR 8-17) vs 11 (IQR 7-20) days, absolute risk difference -1.0% (95% CI -3.1% to +1.1%)).

CONCLUSIONS

Among patients with COVID-19 pneumonia and mild hypoxaemia, the use of HFNO did not significantly reduce the likelihood of escalation of respiratory support.

TRIAL REGISTRATION NUMBER

NCT04655638.

摘要

原理

在新型冠状病毒肺炎（COVID-19）合并轻度低氧血症的患者中，高流量鼻导管给氧（HFNO）的临床益处仍不明确。我们旨在研究在该患者群体中，与传统氧疗（COT）相比，HFNO是否能预防呼吸支持的升级。

方法

在这项多中心、随机、平行组、开放标签试验中，将需要氧疗的COVID-19肺炎且外周血氧饱和度（SpO）≤92%的患者随机分为HFNO组或COT组。主要结局是28天内呼吸支持升级的发生率（即持续气道正压通气、无创通气或有创机械通气）。在次要结局中，临床恢复定义为氧合改善（SpO≥96%且吸入氧分数（FiO）≤30%或动脉血二氧化碳分压/FiO比值>300 mmHg）。

结果

在364例随机分组的患者中，分配至HFNO组的181例患者中有55例（30.3%）、分配至COT组的181例患者中有70例（38.6%）出现呼吸支持升级，两组之间无显著差异（绝对风险差 -8.2%（95%CI -18%至 +1.4%）；相对危险度 0.79（95%CI 0.59至1.05）；p = 0.09）。临床恢复（6（9.1%对60.8%；绝对风险差8.2%（95%CI -1.5%至 +18.0%），相对危险度1.14（95%CI 0.98至1.32））、重症监护病房入住率（7.7%对11.0%，绝对风险差 -3.3%（95%CI -9.3%至 +2.6%））以及住院时间（11（四分位间距8 - 17）天对11（四分位间距7 - 20）天，绝对风险差 -（95%CI -3.1%至 +1.1%））方面均无显著差异。