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Randomized Controlled Trial
. 2019 Sep 4;23(1):300.
doi: 10.1186/s13054-019-2575-6.

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

Hangyong He  1 , Bing Sun  1 , Lirong Liang  1 , Yanming Li  2 , He Wang  2 , Luqing Wei  3 , Guofeng Li  3 , Shuliang Guo  4 , Jun Duan  4 , Yuping Li  5 , Ying Zhou  5 , Yusheng Chen  6 , Hongru Li  6 , Jingping Yang  7 , Xiyuan Xu  7 , Liqiang Song  8 , Jie Chen  8 , Yong Bao  9 , Feng Chen  9 , Ping Wang  10 , Lixi Ji  10 , Yongxiang Zhang  11 , Yanyan Ding  11 , Liangan Chen  12 , Ying Wang  12 , Lan Yang  13 , Tian Yang  13 , Heng Weng  14 , Hongyan Li  14 , Daoxin Wang  15 , Jin Tong  15 , Yongchang Sun  16 , Ran Li  16 , Faguang Jin  17 , Chunmei Li  17 , Bei He  18 , Lina Sun  18 , Changzheng Wang  19 , Mingdong Hu  19 , Xiaohong Yang  20 , Qin Luo  20 , Jin Zhang  21 , Hai Tan  21 , Chen Wang  22   23   24   25 ; ENIVA Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Hangyong He et al. Crit Care. .

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.

Keywords: Acute respiratory distress syndrome (ARDS); Noninvasive ventilation (NIV); Pneumonia.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram for the trial. ICU, intensive care unit; NIV, noninvasive ventilation; ALI, acute lung injury; PaO2/FIO2, arterial oxygen tension/inspired oxygen fraction; CT, computed tomography; SOFA, sequential organ failure assessment; PaCO2, arterial pressure of carbon dioxide
Fig. 2
Fig. 2
Kaplan-Meier estimates of the probability of the need for endotracheal intubation based on the criteria for endotracheal intubation. No difference was found for the cumulative probability for endotracheal intubation of the two groups (log-rank test: p = 0.71)
Fig. 3
Fig. 3
Kaplan-Meier estimates of the probability of mortality. No difference was found for the cumulative probability for endotracheal intubation of the two groups (log-rank test: p = 0.94)
Fig. 4
Fig. 4
Comparisons of physiological parameters between noninvasive ventilation and control groups
Fig. 5
Fig. 5
Comparisons of physiological parameters between noninvasive ventilation success and failure groups
See this image and copyright information in PMC

Comment in

References

    1. Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, et al. Epidemiology, patterns of care, and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA. 2016;315(8):788–800. doi: 10.1001/jama.2016.0291. - DOI - PubMed
    1. Brambilla AM, Aliberti S, Prina E, Nicoli F, Del Forno M, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, et al. Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia. Intensive Care Med. 2014;40(7):942–949. doi: 10.1007/s00134-014-3325-5. - DOI - PubMed
    1. Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, et al. Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005;293(5):589–595. doi: 10.1001/jama.293.5.589. - DOI - PubMed
    1. Xu XP, Zhang XC, Hu SL, Xu JY, Xie JF, Liu SQ, Liu L, Huang YZ, Guo FM, Yang Y, et al. Noninvasive ventilation in acute hypoxemic nonhypercapnic respiratory failure: a systematic review and meta-analysis. Crit Care Med. 2017;45(7):e727–e733. doi: 10.1097/CCM.0000000000002361. - DOI - PMC - PubMed
    1. Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, et al. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007;35(1):18–25. doi: 10.1097/01.CCM.0000251821.44259.F3. - DOI - PubMed

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