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Published in: Critical Care 1/2019

Open Access 01-12-2019 | Pneumonia | Research

A multicenter RCT of noninvasive ventilation in pneumonia-induced early mild acute respiratory distress syndrome

Authors: Hangyong He, Bing Sun, Lirong Liang, Yanming Li, He Wang, Luqing Wei, Guofeng Li, Shuliang Guo, Jun Duan, Yuping Li, Ying Zhou, Yusheng Chen, Hongru Li, Jingping Yang, Xiyuan Xu, Liqiang Song, Jie Chen, Yong Bao, Feng Chen, Ping Wang, Lixi Ji, Yongxiang Zhang, Yanyan Ding, Liangan Chen, Ying Wang, Lan Yang, Tian Yang, Heng Weng, Hongyan Li, Daoxin Wang, Jin Tong, Yongchang Sun, Ran Li, Faguang Jin, Chunmei Li, Bei He, Lina Sun, Changzheng Wang, Mingdong Hu, Xiaohong Yang, Qin Luo, Jin Zhang, Hai Tan, Chen Wang, for the ENIVA Study Group

Published in: Critical Care | Issue 1/2019

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Abstract

Rationale

Our pilot study suggested that noninvasive ventilation (NIV) reduced the need for intubation compared with conventional administration of oxygen on patients with “early” stage of mild acute respiratory distress syndrome (ARDS, PaO2/FIO2 between 200 and 300).

Objectives

To evaluate whether early NIV can reduce the need for invasive ventilation in patients with pneumonia-induced early mild ARDS.

Methods

Prospective, multicenter, randomized controlled trial (RCT) of NIV compared with conventional administration of oxygen through a Venturi mask. Primary outcome included the numbers of patients who met the intubation criteria.

Results

Two hundred subjects were randomized to NIV (n = 102) or control (n = 98) groups from 21 centers. Baseline characteristics were similar in the two groups. In the NIV group, PaO2/FIO2 became significantly higher than in the control group at 2 h after randomization and remained stable for the first 72 h. NIV did not decrease the proportion of patients requiring intubation than in the control group (11/102 vs. 9/98, 10.8% vs. 9.2%, p = 0.706). The ICU mortality was similar in the two groups (7/102 vs. 7/98, 4.9% vs. 3.1%, p = 0.721). Multivariate analysis showed minute ventilation greater than 11 L/min at 48 h was the independent risk factor for NIV failure (OR, 1.176 [95% CI, 1.005–1.379], p = 0.043).

Conclusions

Treatment with NIV did not reduce the need for intubation among patients with pneumonia-induced early mild ARDS, despite the improved PaO2/FIO2 observed with NIV compared with standard oxygen therapy. High minute ventilation may predict NIV failure.

Trial registration

NCT01581229. Registered 19 April 2012
Appendix
Available only for authorised users
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Metadata
Title
A multicenter RCT of noninvasive ventilation in pneumonia-induced early mild acute respiratory distress syndrome
Authors
Hangyong He
Bing Sun
Lirong Liang
Yanming Li
He Wang
Luqing Wei
Guofeng Li
Shuliang Guo
Jun Duan
Yuping Li
Ying Zhou
Yusheng Chen
Hongru Li
Jingping Yang
Xiyuan Xu
Liqiang Song
Jie Chen
Yong Bao
Feng Chen
Ping Wang
Lixi Ji
Yongxiang Zhang
Yanyan Ding
Liangan Chen
Ying Wang
Lan Yang
Tian Yang
Heng Weng
Hongyan Li
Daoxin Wang
Jin Tong
Yongchang Sun
Ran Li
Faguang Jin
Chunmei Li
Bei He
Lina Sun
Changzheng Wang
Mingdong Hu
Xiaohong Yang
Qin Luo
Jin Zhang
Hai Tan
Chen Wang
for the ENIVA Study Group
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2019
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-019-2575-6

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