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

doi:10.1186/s13054-019-2575-6

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 He¹, Bing Sun¹, Lirong Liang¹, Yanming Li², He Wang², Luqing Wei³, Guofeng Li³, Shuliang Guo⁴, Jun Duan⁴, Yuping Li⁵, Ying Zhou⁵, Yusheng Chen⁶, Hongru Li⁶, Jingping Yang⁷, Xiyuan Xu⁷, Liqiang Song⁸, Jie Chen⁸, Yong Bao⁹, Feng Chen⁹, Ping Wang¹⁰, Lixi Ji¹⁰, Yongxiang Zhang¹¹, Yanyan Ding¹¹, Liangan Chen¹², Ying Wang¹², Lan Yang¹³, Tian Yang¹³, Heng Weng¹⁴, Hongyan Li¹⁴, Daoxin Wang¹⁵, Jin Tong¹⁵, Yongchang Sun¹⁶, Ran Li¹⁶, Faguang Jin¹⁷, Chunmei Li¹⁷, Bei He¹⁸, Lina Sun¹⁸, Changzheng Wang¹⁹, Mingdong Hu¹⁹, Xiaohong Yang²⁰, Qin Luo²⁰, Jin Zhang²¹, Hai Tan²¹, Chen Wang^{22

23

24

25}; ENIVA Study Group

Collaborators, Affiliations

Collaborators

ENIVA Study Group:
Hangyong He, Bing Sun, Lirong Liang, Yanming Li, He Wang, Luqing Wei, Guofeng Li, Bin Liu, Shuliang Guo, Jun Duan, Yuping Li, Ying Zhou, Yusheng Chen, Hongru Li, Rujun Hong, Xiujuan Yao, Fengfeng Lu, Jingping Yang, Xiyuan Xu, Hui Wang, Ling Wang, Hongjun Tian, Liqiang Song, Jie Chen, Yunfu Wu, Yong Bao, Feng Chen, Ping Wang, Lixi Ji, Xiaofang Huang, Min Sun, Yongxiang Zhang, Yanyan Ding, Liangan Chen, Ying Wang, Zhixin Liang, Lan Yang, Tian Yang, Heng Weng, Hongyan Li, Xu Lin, Daoxin Wang, Jin Tong, Wang Deng, Yongchang Sun, Ran Li, Jie Xu, Faguang Jin, Yandong Nan, Chunmei Li, Bei He, Ning Shen, Lina Sun, Changzheng Wang, Mingdong Hu, Xiaohong Yang, Qin Luo, Mei Li, Jin Zhang, Hai Tan, Chen Wang

Affiliations

¹ Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Beijing Engineering Research Center for Diagnosis and Treatment of Pulmonary and Critical Care, Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, China.
² Department of Respiratory and Critical Care Medicine, Beijing Hospital, Beijing, China.
³ Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Logistics College of Chinese Armed Police Forces, Tianjin, China.
⁴ Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
⁵ Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.
⁶ The Pulmonary Department, Fujian Province Hospital, Fuzhou, Fujian Province, China.
⁷ Department of Respiratory and Critical Care Medicine, The Third Affiliated Hospital of Inner Mongolia Medical College, Baotou, Inner Mongolia Autonomous Region, China.
⁸ The Pulmonary Department, Xijing Hospital of the Fourth Military Medical University, Xi'an, Shanxi Province, China.
⁹ The Pulmonary Department, The Third People's Hospital of Chengdu, Chengdu, Sichuan Province, China.
¹⁰ Department of Critical Care Medicine, Chengdu Fifth People's Hospital, Chengdu, Sichuan Province, China.
¹¹ Department of Respiratory Medicine, People's Hospital of Beijing Daxing District, Beijing, China.
¹² Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital, Beijing, China.
¹³ Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi Province, China.
¹⁴ The Pulmonary Department, Lung Disease Hospital of Fujian Fuzhou, Fuzhou, Fujian Province, China.
¹⁵ The Pulmonary Department, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
¹⁶ The Pulmonary Department, Beijing Tongren Hospital, Beijing, China.
¹⁷ Department of Respiratory and Critical Care Medicine, Tangdu Hospital, the Fourth Military Medical University, Xi'an, Shanxi Province, China.
¹⁸ The Pulmonary Department, Peking University Third Hospital, Beijing, China.
¹⁹ The Pulmonary Department, Xinqiao Hospital Army Medical University, Chongqing, China.
²⁰ Department of Respiratory and Critical Care Medicine, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Uygur Autonomous Region, China.
²¹ Department of Respiratory and Critical Care Medicine, General Hospital of Ningxia Medical University, Yinchuan, Ningxia Province, China.
²² Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. cyh-birm@263.net.
²³ Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No.2 Yinghua East Road, Chaoyang District, Beijing, 100029, China. cyh-birm@263.net.
²⁴ Department of Respiratory Medicine, Capital Medical University, Beijing, China. cyh-birm@263.net.
²⁵ National Clinical Research Center for Respiratory Diseases, Beijing, China. cyh-birm@263.net.

PMID: 31484582
PMCID: PMC6727327
DOI: 10.1186/s13054-019-2575-6

Randomized Controlled Trial

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

Hangyong He et al. Crit Care. 2019.

. 2019 Sep 4;23(1):300.

doi: 10.1186/s13054-019-2575-6.

Authors

Collaborators

ENIVA Study Group:
Hangyong He, Bing Sun, Lirong Liang, Yanming Li, He Wang, Luqing Wei, Guofeng Li, Bin Liu, Shuliang Guo, Jun Duan, Yuping Li, Ying Zhou, Yusheng Chen, Hongru Li, Rujun Hong, Xiujuan Yao, Fengfeng Lu, Jingping Yang, Xiyuan Xu, Hui Wang, Ling Wang, Hongjun Tian, Liqiang Song, Jie Chen, Yunfu Wu, Yong Bao, Feng Chen, Ping Wang, Lixi Ji, Xiaofang Huang, Min Sun, Yongxiang Zhang, Yanyan Ding, Liangan Chen, Ying Wang, Zhixin Liang, Lan Yang, Tian Yang, Heng Weng, Hongyan Li, Xu Lin, Daoxin Wang, Jin Tong, Wang Deng, Yongchang Sun, Ran Li, Jie Xu, Faguang Jin, Yandong Nan, Chunmei Li, Bei He, Ning Shen, Lina Sun, Changzheng Wang, Mingdong Hu, Xiaohong Yang, Qin Luo, Mei Li, Jin Zhang, Hai Tan, Chen Wang

Affiliations

¹ Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Beijing Engineering Research Center for Diagnosis and Treatment of Pulmonary and Critical Care, Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, China.
² Department of Respiratory and Critical Care Medicine, Beijing Hospital, Beijing, China.
³ Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Logistics College of Chinese Armed Police Forces, Tianjin, China.
⁴ Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
⁵ Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.
⁶ The Pulmonary Department, Fujian Province Hospital, Fuzhou, Fujian Province, China.
⁷ Department of Respiratory and Critical Care Medicine, The Third Affiliated Hospital of Inner Mongolia Medical College, Baotou, Inner Mongolia Autonomous Region, China.
⁸ The Pulmonary Department, Xijing Hospital of the Fourth Military Medical University, Xi'an, Shanxi Province, China.
⁹ The Pulmonary Department, The Third People's Hospital of Chengdu, Chengdu, Sichuan Province, China.
¹⁰ Department of Critical Care Medicine, Chengdu Fifth People's Hospital, Chengdu, Sichuan Province, China.
¹¹ Department of Respiratory Medicine, People's Hospital of Beijing Daxing District, Beijing, China.
¹² Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital, Beijing, China.
¹³ Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi Province, China.
¹⁴ The Pulmonary Department, Lung Disease Hospital of Fujian Fuzhou, Fuzhou, Fujian Province, China.
¹⁵ The Pulmonary Department, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
¹⁶ The Pulmonary Department, Beijing Tongren Hospital, Beijing, China.
¹⁷ Department of Respiratory and Critical Care Medicine, Tangdu Hospital, the Fourth Military Medical University, Xi'an, Shanxi Province, China.
¹⁸ The Pulmonary Department, Peking University Third Hospital, Beijing, China.
¹⁹ The Pulmonary Department, Xinqiao Hospital Army Medical University, Chongqing, China.
²⁰ Department of Respiratory and Critical Care Medicine, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Uygur Autonomous Region, China.
²¹ Department of Respiratory and Critical Care Medicine, General Hospital of Ningxia Medical University, Yinchuan, Ningxia Province, China.
²² Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. cyh-birm@263.net.
²³ Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No.2 Yinghua East Road, Chaoyang District, Beijing, 100029, China. cyh-birm@263.net.
²⁴ Department of Respiratory Medicine, Capital Medical University, Beijing, China. cyh-birm@263.net.
²⁵ National Clinical Research Center for Respiratory Diseases, Beijing, China. cyh-birm@263.net.

PMID: 31484582
PMCID: PMC6727327
DOI: 10.1186/s13054-019-2575-6

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.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**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**
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**
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**
Comparisons of physiological parameters between noninvasive ventilation and control groups

**Fig. 5**
Comparisons of physiological parameters between noninvasive ventilation success and failure groups

See this image and copyright information in PMC

Comment in

Noninvasive ventilation in patients with acute respiratory distress syndrome.
Du K. Du K. Crit Care. 2019 Nov 15;23(1):358. doi: 10.1186/s13054-019-2666-4. Crit Care. 2019. PMID: 31730002 Free PMC article. No abstract available.

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References

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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
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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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[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

[2] 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

[3] 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

[4] 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

[5] 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

[6] 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

[7] 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

[8] 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

[9] 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

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

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

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