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一项多中心随机对照试验,比较了小婴儿严重病毒性毛细支气管炎患者使用 3L/kg/min 与 2L/kg/min 高流量鼻导管吸氧流速的效果(TRAMONTANE 2)。

A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2).

机构信息

Department of Neonatal Medicine and Pediatric Intensive Care, Arnaud de Villeneuve University Hospital, 371 Avenue Doyen G Giraud, 34295, Montpellier Cedex 5, France.

Pediatric Intensive Care Unit, Kremlin Bicêtre University Hospital, Paris, France.

出版信息

Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.

DOI:10.1007/s00134-018-5343-1
PMID:30343318
Abstract

PURPOSE

High-flow nasal cannula (HFNC) therapy is increasingly proposed as first-line respiratory support for infants with acute viral bronchiolitis (AVB). Most teams use 2 L/kg/min, but no study compared different flow rates in this setting. We hypothesized that 3 L/kg/min would be more efficient for the initial management of these patients.

METHODS

A randomized controlled trial was performed in 16 pediatric intensive care units (PICUs) to compare these two flow rates in infants up to 6 months old with moderate to severe AVB and treated with HFNC. The primary endpoint was the percentage of failure within 48 h of randomization, using prespecified criteria of worsening respiratory distress and discomfort.

RESULTS

From November 2016 to March 2017, 142 infants were allocated to the 2-L/kg/min (2L) flow rate and 144 to the 3-L/kg/min (3L) flow rate. Failure rate was comparable between groups: 38.7% (2L) vs. 38.9% (3L; p = 0.98). Worsening respiratory distress was the most common cause of failure in both groups: 49% (2L) vs. 39% (3L; p = 0.45). In the 3L group, discomfort was more frequent (43% vs. 16%, p = 0.002) and PICU stays were longer (6.4 vs. 5.3 days, p = 0.048). The intubation rates [2.8% (2L) vs. 6.9% (3L), p = 0.17] and durations of invasive [0.2 (2L) vs. 0.5 (3L) days, p = 0.10] and noninvasive [1.4 (2L) vs. 1.6 (3L) days, p = 0.97] ventilation were comparable. No patient had air leak syndrome or died.

CONCLUSION

In young infants with AVB supported with HFNC, 3 L/kg/min did not reduce the risk of failure compared with 2 L/kg/min. This clinical trial was recorded on the National Library of Medicine registry (NCT02824744).

摘要

目的

高流量鼻导管(HFNC)治疗越来越被提议作为急性病毒性细支气管炎(AVB)婴儿的一线呼吸支持。大多数团队使用 2 L/kg/min,但没有研究比较在这种情况下的不同流速。我们假设 3 L/kg/min 对这些患者的初始管理更有效。

方法

在 16 个儿科重症监护病房(PICU)中进行了一项随机对照试验,以比较这两种流速在 6 个月以下、接受 HFNC 治疗的中重度 AVB 婴儿中的应用。主要终点是在随机分组后 48 小时内的失败率,使用预先指定的呼吸窘迫和不适加重的标准。

结果

2016 年 11 月至 2017 年 3 月,142 名婴儿被分配到 2 L/kg/min(2L)流速组和 144 名婴儿被分配到 3 L/kg/min(3L)流速组。两组的失败率相似:38.7%(2L)与 38.9%(3L)(p=0.98)。在两组中,呼吸窘迫恶化都是失败的最常见原因:49%(2L)与 39%(3L)(p=0.45)。在 3L 组中,不适更常见(43%比 16%,p=0.002),PICU 住院时间更长(6.4 比 5.3 天,p=0.048)。插管率[2.8%(2L)与 6.9%(3L),p=0.17]和有创[0.2 天(2L)与 0.5 天(3L),p=0.10]和无创[1.4 天(2L)与 1.6 天(3L),p=0.97]通气的持续时间相当。没有患者发生气胸综合征或死亡。

结论

在接受 HFNC 支持的 AVB 婴儿中,与 2 L/kg/min 相比,3 L/kg/min 并不能降低失败的风险。本临床试验已在国家医学图书馆注册(NCT02824744)。

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A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis.随机对照试验:高流量氧疗在毛细支气管炎患儿中的应用
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