普通病房中急性呼吸衰竭的早期无创通气：一项国际多中心开放标签随机试验

Early noninvasive ventilation in general wards for acute respiratory failure: an international, multicentre, open-label, randomised trial.

作者信息

Monti Giacomo, Cabrini Luca, Kotani Yuki, Brusasco Claudia, Kadralinova Assiya, Giardina Giuseppe, Chalkias Athanasios, Nakhnoukh Cristina, Pantazopoulos Ioannis, Oliva Federico Mattia, Dazzi Federico, Roasio Agostino, Baiardo Redaelli Martina, Tripodi Vincenzo Francesco, Cucciolini Giada, Belletti Alessandro, Vaschetto Rosanna, Maj Giulia, Borghi Giovanni, Savelli Francesco, Boni Silvia, D'Amico Filippo, Cavallero Sarah, Labanca Rosa, Tresoldi Moreno, Marmiere Marilena, Marzaroli Matteo, Moizo Elena, Monaco Fabrizio, Nardelli Pasquale, Pieri Marina, Plumari Valentina, Scandroglio Anna Mara, Turi Stefano, Corradi Francesco, Konkayev Aidos, Landoni Giovanni, Bellomo Rinaldo, Zangrillo Alberto

机构信息

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

Department of Biotechnologies and Life Science, University of Insubria, Varese, Italy; Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi di Varese, Varese, Italy.

出版信息

Br J Anaesth. 2025 Feb;134(2):382-391. doi: 10.1016/j.bja.2024.11.023. Epub 2025 Jan 2.

DOI:10.1016/j.bja.2024.11.023

PMID:39753402

Abstract

BACKGROUND

The impact of noninvasive ventilation (NIV) managed outside the intensive care unit in patients with early acute respiratory failure remains unclear. We aimed to determine whether adding early NIV prevents the progression to severe respiratory failure.

METHODS

In this multinational, randomised, open-label controlled trial, adults with mild acute respiratory failure (arterial oxygen partial pressure/fraction of inspiratory oxygen [Pao/FiO] ratio ≥200) were enrolled across 11 hospitals in Italy, Greece, and Kazakhstan. Patients were randomised to receive early NIV or usual care. Patients in the early NIV group received 2-h cycles of NIV applied every 8 h for up to 12 days. The primary outcome was the progression to severe acute respiratory failure, defined by severe hypoxaemia, severe respiratory distress, or hypercapnic acidaemia during hospitalisation.

RESULTS

Between May 6, 2012, and July 18, 2023, we randomised 524 patients (44.8% female; median age 73 yr, interquartile range [IQR] 63-83 yr). One patient withdrew consent. Progression to severe acute respiratory failure occurred in 49/265 (18.5%) patients randomised to early NIV, compared with 73/258 (28.3%) patients receiving usual care (relative risk 0.65, 95% confidence interval 0.48-0.90, P=0.0080). Median length of hospital stay was 10 (IQR 6-16) days in the early NIV group and 9 (IQR 5-16) days in the usual care group (P=0.30). Respiratory complications, 28-day mortality, and adverse events were not different between early NIV and usual care.

CONCLUSIONS

In patients with mild acute respiratory failure treated in nonintensive care wards, early NIV reduced the progression to severe acute respiratory failure.

CLINICAL TRIAL REGISTRATION

NCT01572337.

摘要

背景

在重症监护病房之外进行无创通气（NIV）对早期急性呼吸衰竭患者的影响尚不清楚。我们旨在确定早期应用NIV是否可预防病情进展为严重呼吸衰竭。

方法

在这项多国、随机、开放标签对照试验中，来自意大利、希腊和哈萨克斯坦11家医院的轻度急性呼吸衰竭（动脉血氧分压/吸入氧分数[Pao/FiO]比值≥200）成年患者被纳入研究。患者被随机分配接受早期NIV或常规治疗。早期NIV组患者每8小时接受2小时的NIV治疗周期，持续12天。主要结局是进展为严重急性呼吸衰竭，定义为住院期间出现严重低氧血症、严重呼吸窘迫或高碳酸血症性酸中毒。

结果

在2012年5月6日至2023年7月18日期间，我们随机分配了524例患者（女性占44.8%；中位年龄73岁，四分位间距[IQR]为63 - 83岁）。1例患者撤回同意书。随机分配至早期NIV组的265例患者中有49例（18.5%）进展为严重急性呼吸衰竭，而接受常规治疗的258例患者中有73例（28.3%）进展为严重急性呼吸衰竭（相对风险0.65，95%置信区间0.48 - 0.90，P = 0.0080）。早期NIV组的中位住院时间为10（IQR 6 - 16）天，常规治疗组为9（IQR 5 - 16）天（P = 0.30）。早期NIV组与常规治疗组在呼吸并发症、28天死亡率及不良事件方面无差异。