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BMC Pulm Med. 2017 Sep 20;17(1):127. doi: 10.1186/s12890-017-0467-6.

The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM).

Wang T1, Liu G2, He K3, Lu X1, Liang X4, Wang M5, Zhu R6, Li Z1, Chen F7, Ke J7, Lin Q7, Qian C8, Li B8, Wei J9, Lv J9, Li L10, Gao Y10, Wu G11, Yu X11, Wei W11, Deng Y12, Wang F12, Zhang H13, Zheng Y13, Zhan H14, Liao J14, Tian Y15, Yao D15, Zhang J16, Chen X16, Yang L17, Wu J17, Chai Y18, Shou S18, Yu M18, Xiang X19, Zhang D19, Chen F20, Xie X20, Li Y21, Wang B21, Zhang W22, Miao Y22, Eddleston M23, He J1, Ma Y1, Xu S1, Li Y24, Zhu H25, Yu X26.

Author information

1
Emergency Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China.
2
Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.
3
Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.
4
Emergency Department, Guiyang Second People Hospital, Guiyang, China.
5
Department of Science and Technology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, China.
6
Department of Ultrasound, Peking Union Medical College Hospital, Beijing, China.
7
Department of Emergency, Fujian Provincial Hospital, Provincial Clinical Medical College of Fujian Medical University, Fuzhou, China.
8
Emergency Department, First Affiliated Hospital of Kunming Medical University, Kunming, China.
9
Department of Emergency, Renmin Hospital of Wuhan University, Wuhan, China.
10
Emergency Department, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
11
Emergency Department, Affiliated Hospital of Guizhou Medical University, Guiyang, China.
12
Department of Emergency, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.
13
Department of Emergency, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
14
Department of Emergency Medicine, The First Affiliated Hospital of SUN Yat-sen University, Guangzhou, China.
15
Emergency Department, Second Hospital of Hebei Medical University, Shijiazhuang, China.
16
Department of Emergency, First affiliated hospital of Nanjing Medical University, Nanjing, China.
17
Department of Emergency, General Hospital of Ningxia Medical University, Yinchuan, China.
18
Emergency Department, Tianjin Medical University General Hospital, Tianjin, China.
19
Department of Emergency Medicine, Second Xiangya Hospital, Institute of Emergency Medicine and Difficult Diseases, Central South University, Changsha, China.
20
Department of Emergency, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.
21
Department of Emergency, Cangzhou City Center Hospital, Cangzhou, China.
22
Department of Emergency, First Hospital of Handan City, Handan, China.
23
Pharmacology, Toxicology and Therapeutics, Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
24
Emergency Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China. billliyi@126.com.
25
Emergency Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China. zhuhuadong1970@126.com.
26
Emergency Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China. yxz@medmail.com.cn.

Abstract

BACKGROUND:

Acute respiratory failure (ARF) is still one of the most severe complications in immunocompromised patients. Our previous systematic review showed noninvasive mechanical ventilation (NIV) reduced mortality, length of hospitalization and ICU stay in AIDS/hematological malignancy patients with relatively less severe ARF, compared to invasive mechanical ventilation (IMV). However, this systematic review was based on 13 observational studies and the quality of evidence was low to moderate. The efficacy of NIV in more severe ARF and in patients with other causes of immunodeficiency is still unclear. We aim to determine the efficacy of the initial ventilation strategy in managing ARF in immunocompromised patients stratified by different disease severity and causes of immunodeficiency, and explore predictors for failure of NIV.

METHODS AND ANALYSIS:

The VENIM is a multicentre randomized controlled trial (RCT) comparing the effects of NIV compared with IMV in adult immunocompromised patients with severe hypoxemic ARF. Patients who meet the indications for both forms of ventilatory support will be included. Primary outcome will be 30-day all-cause mortality. Secondary outcomes will include in-hospital mortality, length of stay in hospital, improvement of oxygenation, nosocomial infections, seven-day organ failure, adverse events of intervention, et al. Subgroups with different disease severity and causes of immunodeficiency will also be analyzed.

DISCUSSION:

VENIM is the first randomized controlled trial aiming at assessing the efficacy of initial ventilation strategy in treating moderate and severe acute respiratory failure in immunocompromised patients. The result of this RCT may help doctors with their ventilation decisions.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02983851 . Registered 2 September 2016.

KEYWORDS:

Acute respiratory failure; Immunocompromised patients; Invasive mechanical ventilation; Noninvasive mechanical ventilation; Ventilation strategy

PMID:
28931394
PMCID:
PMC5607592
DOI:
10.1186/s12890-017-0467-6
[Indexed for MEDLINE]
Free PMC Article

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